Advanced electrode array insertion

ABSTRACT

An apparatus including an actuator and an electrode array support, wherein the apparatus is configured to insert an electrode array into a cochlea via controlled actuation of the actuator, wherein the controlled actuation is at least partially based on data that is at least partially based on electrical characteristics associated with the recipient.

BACKGROUND

Hearing loss, which may be due to many different causes, is generally oftwo types: conductive and sensorineural. Sensorineural hearing loss isdue to the absence or destruction of the hair cells in the cochlea thattransduce sound signals into nerve impulses. Various hearing prosthesesare commercially available to provide individuals suffering fromsensorineural hearing loss with the ability to perceive sound. Oneexample of a hearing prosthesis is a cochlear implant.

Conductive hearing loss occurs when the normal mechanical pathways thatprovide sound to hair cells in the cochlea are impeded, for example, bydamage to the ossicular chain or the ear canal. Individuals sufferingfrom conductive hearing loss may retain some form of residual hearingbecause the hair cells in the cochlea may remain undamaged.

Individuals suffering from hearing loss typically receive an acoustichearing aid. Conventional hearing aids rely on principles of airconduction to transmit acoustic signals to the cochlea. In particular, ahearing aid typically uses an arrangement positioned in the recipient'sear canal or on the outer ear to amplify a sound received by the outerear of the recipient. This amplified sound reaches the cochlea causingmotion of the perilymph and stimulation of the auditory nerve. Cases ofconductive hearing loss typically are treated by means of boneconduction hearing aids. In contrast to conventional hearing aids, thesedevices use a mechanical actuator that is coupled to the skull bone toapply the amplified sound.

In contrast to hearing aids, which rely primarily on the principles ofair conduction, certain types of hearing prostheses commonly referred toas cochlear implants convert a received sound into electricalstimulation. The electrical stimulation is applied to the cochlea, whichresults in the perception of the received sound.

It is noted that in at least some instances, there is utilitarian valueto fitting a hearing prosthesis to a particular recipient. In someexamples of some fitting regimes, there are methods which entail aclinician or some other professional presenting sounds to a recipient ofthe hearing prosthesis such that the hearing prosthesis evokes a hearingpercept. Information can be obtained from the recipient regarding thecharacter of the resulting hearing percept. Based on this information,the clinician can adjust or otherwise establish settings of the hearingprosthesis such that the hearing prosthesis operates according to thesesettings during normal use.

It is also noted that the electrode array of the cochlear implantgenerally shows utilitarian results if it is inserted in a cochlea.

SUMMARY

In accordance with an exemplary embodiment, there is an apparatus,comprising an actuator and electrode array support, wherein theapparatus is configured to insert an electrode array into a cochlea viacontrolled actuation of the actuator, wherein the controlled actuationis at least partially based on data that is at least partially based onelectrical characteristics associated with the recipient.

In accordance with an exemplary embodiment, there is a system,comprising a robotic assembly configured to move an electrode arrayrelative to the cochlea, and a control unit configured to receive databased on electrical phenomenon inside the recipient and control therobotic assembly based at least in part on the received data.

In accordance with another exemplary embodiment, there is a method,comprising advancing at least a first portion of an electrode array intoa cochlea of a recipient during a first temporal period at leastpartially assisted by activation of an actuator that moves the electrodearray monitoring an electrical phenomenon within the recipient at leastone of during the first temporal period or during a second temporalperiod subsequent to the first temporal period, and controlling theactuator based on the action of monitoring.

In accordance with another exemplary embodiment, there is a method,comprising inserting an electrode array into a cochlea of a recipientutilizing a robotic apparatus by controlling the robotic apparatus atleast partially based on electrical phenomenon associated with therecipient.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments are described below with reference to the attached drawings,in which:

FIG. 1 is a perspective view of an exemplary hearing prosthesis in whichat least some of the teachings detailed herein are applicable;

FIG. 2 is a side view of an embodiment of an insertion guide forimplanting a cochlear implant electrode assembly such as the electrodeassembly illustrated in FIG. 1;

FIGS. 3A and 3B are side and perspective views of an electrode assemblyextended out of an embodiment of an insertion sheath of the insertionguide illustrated in FIG. 2;

FIGS. 4A-4E are simplified side views depicting the position andorientation of a cochlear implant electrode assembly insertion guidetube relative to the cochlea at each of a series of successive momentsduring an exemplary implantation of the electrode assembly into thecochlea;

FIG. 5A is a side view of a perimodiolar electrode assembly partiallyextended out of a conventional insertion guide tube showing how theassembly may twist while in the guide tube;

FIGS. 5B-5I are cross-sectional views of the electrode assemblyillustrated in FIG. 5A;

FIG. 6A is a cross-sectional view of an embodiment of the insertionguide tube;

FIG. 6B is a perspective view of the portion of the guide tubeillustrated in FIG. 6A;

FIG. 6C is a cross-sectional view of a conventional electrode assembly;

FIG. 6D is a cross-sectional view of the conventional electrode assemblyof FIG. 6C positioned in the insertion guide tube illustrated in FIGS.6A and 6B;

FIGS. 7 and 8 depict side views of respective exemplary embodiments ofexemplary electrode array insertion guides;

FIGS. 9-10B depicts side views of various exemplary embodiments ofvarious insertion guides in use;

FIGS. 11-18 depict cross-sectional views of portions of the insertionguide tube of exemplary embodiments of the electrode array insertionguide;

FIGS. 19-27 depict side views of exemplary embodiments of exemplaryelectrode array insertion guides;

FIG. 28 depicts an exemplary use of an exemplary electrode arrayinsertion guide;

FIGS. 29-35 depict side views of exemplary embodiments of exemplaryelectrode array insertion guides;

FIGS. 36-37 depict exemplary functional block diagrams associated withthe exemplary electrode array insertion guides;

FIGS. 38-39 depict side views of exemplary embodiments of exemplaryelectrode array insertion guides;

FIG. 40 depicts an exemplary functional block diagram associated withthe exemplary electrode array insertion guides;

FIGS. 41-44 depict cross-sectional views of portions of the insertionguide tube of exemplary embodiments of the electrode array insertionguide;

FIG. 45 is a quasi-functional schematic of an electrode array accordingto an exemplary embodiment;

FIG. 46 is a schematic of a conductive apparatus according to anexemplary embodiment;

FIG. 47 is another view of the conductive apparatus of FIG. 46;

FIG. 48A depicts the view of FIG. 7, along with a cross-sectional viewof an electrode array located in the conductive apparatus;

FIG. 48B depicts a cross-sectional view of a portion of the insertionguide tube of exemplary embodiments of the electrode array insertionguide;

FIG. 49 depicts an exemplary scenario associated with testing anelectrode array for an open circuit utilizing a component of aninsertion guide;

FIG. 50A depicts a conceptual diagram depicting a test for an opencircuit;

FIG. 50B depicts a conceptual diagram depicting an open circuit that canbe detected utilizing the test for an open circuit;

FIGS. 51A-51C depict exemplary conductive apparatus is that can beutilized to test for open circuit according to some exemplaryembodiments;

FIG. 52 depicts an exemplary cross-sectional view of an exemplaryembodiment of an exemplary insertion guide;

FIGS. 53-54 depict side views of exemplary embodiments of exemplaryelectrode array insertion guides;

FIGS. 55-56 depict exemplary cross-sectional views of an exemplaryembodiment of an exemplary insertion guide;

FIG. 57 depicts an exemplary side view of an exemplary embodiment of anexemplary insertion guide;

FIG. 58 depicts an exemplary cross-sectional view of an exemplaryportion of an exemplary insertion guide;

FIG. 59 depicts an exemplary side view of an exemplary embodiment of anexemplary insertion guide;

FIG. 60 depicts an exemplary cross-sectional view of an exemplaryportion of an exemplary insertion guide;

FIGS. 61-63 depict side views of exemplary embodiments of exemplaryelectrode array insertion guides;

FIG. 64 depicts an exemplary flowchart for an exemplary method accordingto an exemplary embodiment;

FIGS. 65-67 depict side views of exemplary embodiments of exemplaryelectrode array insertion guides;

FIGS. 68-70 depict exemplary flowcharts for exemplary methods accordingto some exemplary embodiments;

FIG. 71 depicts an exemplary thin-film that is usable for an exemplaryembodiment;

FIG. 72 depicts the results of the utilization of the thin film of FIG.71;

FIG. 73 depicts a side view of an exemplary embodiment of an exemplaryinsertion guide;

FIG. 74 depicts an exemplary insertion guide—inductance coil combinationenabling the insertion guide to communicate with a receiver-stimulatorof a cochlear implant;

FIG. 75 depicts an exemplary robotic apparatus according to an exemplaryembodiment;

FIG. 76 depicts an exemplary control unit for the robot of FIG. 75 andvariations thereof;

FIG. 77 depicts an exemplary insertion guide according to anotherexemplary embodiment having an actuator assembly configured to advanceand/or retract the electrode array;

FIGS. 78-80 depict exemplary details of the actuator assembly of FIG.77;

FIG. 81A depicts another exemplary embodiment of an actuator assemblyusable with the embodiment of FIG. 77;

FIGS. 81B-H depict other exemplary embodiments of an actuator assemblyusable with the embodiment of FIG. 77;

FIG. 82 depicts an exemplary embodiment of a insertion tool that can behandheld by a surgeon utilizing the actuator assembly to advance and/orretract the electrode array;

FIG. 83 depicts an exemplary functional diagram of an exemplaryembodiment;

FIG. 84 depicts an exemplary embodiment of an exemplary robot apparatus;

FIG. 85 depicts an exemplary embodiment of an exemplary robot apparatuswith some of the details presented in FIG. 84 removed for claritypurposes associated with this embodiment and the embodiment of FIG. 84;

FIG. 86 presents an exemplary flowchart for an exemplary methodaccording to an exemplary embodiment Nicole and

FIG. 87 depicts an exemplary system according to an exemplary embodimentthat utilizes the robot apparatus according to the teachings detailedherein;

FIG. 88 depicts an exemplary implantable component of a cochlear implantaccording to an exemplary embodiment;

FIG. 89 depicts the cochlear implant of FIG. 88 in signal communicationwith a communication device that enables communication between thecochlear implant and a control unit according to an exemplaryembodiment;

FIGS. 90-95 present exemplary flowcharts for exemplary methods accordingto some exemplary embodiments; and

FIGS. 96-98 depict exemplary flowcharts for feedback regimes accordingto exemplary embodiments.

DETAILED DESCRIPTION

FIG. 1 is a perspective view of an exemplary cochlear implant 100implanted in a recipient having an outer ear 101, a middle ear 105, andan inner ear 107. In a fully functional ear, outer ear 101 comprises anauricle 110 and an ear canal 102. Acoustic pressure or sound waves 103are collected by auricle 110 and channeled into and through ear canal102. Disposed across the distal end of ear canal 102 is a tympanicmembrane 104 that vibrates in response to sound waves 103. Thisvibration is coupled to oval window or fenestra ovalis 112 through thethree bones of the middle ear 105, collectively referred to as theossicles 106, and comprising the malleus 108, the incus 109, and thestapes 111. Ossicles 106 filter and amplify the vibrations delivered bytympanic membrane 104, causing oval window 112 to articulate, orvibrate. This vibration sets up waves of fluid motion of the perilymphwithin cochlea 140. Such fluid motion, in turn, activates hair cells(not shown) inside the cochlea which in turn causes nerve impulses to begenerated which are transferred through spiral ganglion cells (notshown) and auditory nerve 114 to the brain (also not shown) where theyare perceived as sound.

The exemplary cochlear implant illustrated in FIG. 1 is a partiallyimplanted stimulating medical device. Specifically, cochlear implant 100comprises external components 142 attached to the body of the recipient,and internal or implantable components 144 implanted in the recipient.External components 142 typically comprise one or more sound inputelements for detecting sound, such as microphone 124, a sound processor(not shown), and a power source (not shown). Collectively, thesecomponents are housed in a behind-the-ear (BTE) device 126 in theexample depicted in FIG. 1. External components 142 also include atransmitter unit 128 comprising an external coil 130 of a transcutaneousenergy transfer (TET) system. Sound processor 126 processes the outputof microphone 124 and generates encoded stimulation data signals whichare provided to external coil 130.

Internal components 144 comprise an internal receiver unit 132 includinga coil 136 of the TET system, a stimulator unit 120, and an elongatestimulating lead assembly 118. Internal receiver unit 132 and stimulatorunit 120 are hermetically sealed within a biocompatible housing commonlyreferred to as a stimulator/receiver unit. Internal coil 136 of receiverunit 132 receives power and stimulation data from external coil 130.Stimulating lead assembly 118 has a proximal end connected to stimulatorunit 120, and extends through mastoid bone 119. Lead assembly 118 has adistal region, referred to as electrode assembly 145, a portion of whichis implanted in cochlea 140.

Electrode assembly 145 can be inserted into cochlea 140 via acochleostomy 122, or through round window 121, oval window 112,promontory 123, or an opening in an apical turn 147 of cochlea 140.Integrated in electrode assembly 145 is an array 146 oflongitudinally-aligned and distally extending electrode contacts 148 forstimulating the cochlea by delivering electrical, optical, or some otherform of energy. Stimulator unit 120 generates stimulation signals eachof which is delivered by a specific electrode contact 148 to cochlea140, thereby stimulating auditory nerve 114.

Electrode assembly 145 may be inserted into cochlea 140 with the use ofan insertion guide. FIG. 2 is a side view of an embodiment of aninsertion guide for implanting an elongate electrode assembly generallyrepresented by electrode assembly 145 into a mammalian cochlea,represented by cochlea 140. The illustrative insertion guide, referredto herein as insertion guide 200, includes an elongate insertion guidetube 210 configured to be inserted into cochlea 140 and having a distalend 212 from which an electrode assembly is deployed. Insertion guidetube 210 has a radially-extending stop 204 that may be utilized todetermine or otherwise control the depth to which insertion guide tube210 is inserted into cochlea 140.

Insertion guide tube 210 is mounted on a distal region of an elongatestaging section 208 on which the electrode assembly is positioned priorto implantation. A robotic arm adapter 202 is mounted to a proximal endof staging section 208 to facilitate attachment of the guide to a robot,which adapter includes through holes 203 through which bolts can bepassed so as to bolt the guide 200 to a robotic arm, as will be detailedbelow. During use, electrode assembly 145 is advanced from stagingsection 208 to insertion guide tube 210 via ramp 206. After insertionguide tube 210 is inserted to the appropriate depth in cochlea 140,electrode assembly 145 is advanced through the guide tube to exit distalend 212 as described further below.

FIGS. 3A and 3B are side and perspective views, respectively, ofrepresentative electrode assembly 145. As noted, electrode assembly 145comprises an electrode array 146 of electrode contacts 148. Electrodeassembly 145 is configured to place electrode contacts 148 in closeproximity to the ganglion cells in the modiolus. Such an electrodeassembly, commonly referred to as a perimodiolar electrode assembly, ismanufactured in a curved configuration as depicted in FIGS. 3A and 3B.When free of the restraint of a stylet or insertion guide tube,electrode assembly 145 takes on a curved configuration due to it beingmanufactured with a bias to curve, so that it is able to conform to thecurved interior of cochlea 140. As shown in FIG. 3B, when not in cochlea140, electrode assembly 145 generally resides in a plane 350 as itreturns to its curved configuration. That said, it is noted thatembodiments of the insertion guides detailed herein and/or variationsthereof can be applicable to a so-called straight electrode array, whichelectrode array does not curl after being free of a stylet or insertionguide tube etc., but instead remains straight

FIGS. 4A-4E are a series of side-views showing consecutive exemplaryevents that occur in an exemplary implantation of electrode assembly 145into cochlea 140. Initially, electrode assembly 145 and insertion guidetube 310 are assembled. For example, electrode assembly 145 is inserted(slidingly or otherwise) into a lumen of insertion guide tube 300. Thecombined arrangement is then inserted to a predetermined depth intocochlea 140, as illustrated in FIG. 4A. Typically, such an introductionto cochlea 140 is achieved via cochleostomy 122 (FIG. 1) or throughround window 121 or oval window 112. In the exemplary implantation shownin FIG. 4A, the combined arrangement of electrode assembly 145 andinsertion guide tube 300 is inserted to approximately the first turn ofcochlea 140.

As shown in FIG. 4A, the combined arrangement of insertion guide tube300 and electrode assembly 145 is substantially straight. This is due inpart to the rigidity of insertion guide tube 300 relative to the biasforce applied to the interior wall of the guide tube by pre-curvedelectrode assembly 145. This prevents insertion guide tube 300 frombending or curving in response to forces applied by electrode assembly145, thus enabling the electrode assembly to be held straight, as willbe detailed below.

As noted, electrode assembly 145 is biased to curl and will do so in theabsence of forces applied thereto to maintain the straightness. That is,electrode assembly 145 has a memory that causes it to adopt a curvedconfiguration in the absence of external forces. As a result, whenelectrode assembly 145 is retained in a straight orientation in guidetube 300, the guide tube prevents the electrode assembly from returningto its pre-curved configuration. This induces stress in electrodeassembly 145. Pre-curved electrode assembly 145 will tend to twist ininsertion guide tube 300 to reduce the induced stress. In the embodimentconfigured to be implanted in scala tympani of the cochlea, electrodeassembly 145 is pre-curved to have a radius of curvature thatapproximates the curvature of medial side of the scala tympani of thecochlea. Such embodiments of the electrode assembly are referred to as aperimodiolar electrode assembly, and this position within cochlea 140 iscommonly referred to as the perimodiolar position. In some embodiments,placing electrode contacts in the perimodiolar position provides utilitywith respect to the specificity of electrical stimulation, and canreduce the requisite current levels thereby reducing power consumption.

As shown in FIGS. 4B-4D, electrode assembly 145 may be continuallyadvanced through insertion guide tube 300 while the insertion sheath ismaintained in a substantially stationary position. This causes thedistal end of electrode assembly 145 to extend from the distal end ofinsertion guide tube 300. As it does so, the illustrative embodiment ofelectrode assembly 145 bends or curves to attain a perimodiolarposition, as shown in FIGS. 4B-4D, owing to its bias (memory) to curve.Once electrode assembly 145 is located at the desired depth in the scalatympani, insertion guide tube 300 is removed from cochlea 140 whileelectrode assembly 145 is maintained in a stationary position. This isillustrated in FIG. 4E.

Conventional insertion guide tubes typically have a lumen dimensioned toallow the entire tapered electrode assembly to travel through the guidetube. Because the guide tube is able to receive the relatively largerproximal region of the electrode assembly, there will be a gap betweenthe relatively smaller distal region of the electrode assembly and theguide tube lumen wall. Such a gap allows the distal region of theelectrode assembly to curve slightly until the assembly can no longercurve due to the lumen wall.

Returning to FIGS. 3A-3B, perimodiolar electrode assembly 145 ispre-curved in a direction that results in electrode contacts 148 beinglocated on the interior of the curved assembly, as this causes theelectrode contacts to face the modiolus when the electrode assembly isimplanted in or adjacent to cochlea 140. Insertion guide tube 500retains electrode assembly 145 in a substantially straightconfiguration, thereby preventing the assembly from taking on theconfiguration shown in FIG. 3B. The inability of electrode assembly 145to curve to accommodate the bias force induces stress in the assembly.Pre-curved electrode assembly 145 will tend to twist while exitinginsertion guide tube 510 to reduce this stress. With the distal end ofthe electrode assembly curved to abut the lumen wall, the assemblytwists proximally.

This is illustrated in FIGS. 5A-5I. FIG. 5A is a side view ofperimodiolar electrode assembly 145 partially extended out of aconventional insertion guide tube 500, showing how the assembly maytwist while in the guide tube. FIGS. 5B-5F are cross-sectional viewstaken through respective sections 5B-5B, 5C-5C, 5D-5D, 5E-5E, and 5F-5Fof electrode assembly 145 in FIG. 5A.

As shown in FIGS. 5A-5F, the portion of electrode assembly 145 ininsertion guide tube 510 is twisted about its longitudinal axis,resulting in electrode contacts 148 in the twisted region to have adifferent radial position relative to insertion guide tube 510. As shownin FIGS. 5A and 5G-I, as electrode assembly 145 exists insertion guidetube 500, the assembly is free to curve in accordance with its biasforce. However, the orientation of electrode contacts in the deployedregion of the assembly is adversely affected by the twisted region ofthe assembly remaining in guide tube 510.

Accordingly, some embodiments detailed herein and/or variations thereofare directed towards an insertion guide having an insertion guide tubethat maintains a perimodiolar or other pre-curved electrode assembly ina substantially straight configuration while preventing the electrodeassembly from twisting in response to stresses induced by the bias forcewhich urges the assembly to return to its pre-curved configuration. Thisgenerally ensures that when the electrode assembly is deployed from thedistal end of the insertion guide tube, the electrode assembly andinsertion guide tube have a known relative orientation.

FIGS. 6A-6D are different views of but some exemplary embodiments ofinsertion guide tube 210, referred to herein at insertion guide tube610. For ease of description, features of the guide tube will bedescribed with reference to the orientation of the guide tubeillustrated in the figures. FIG. 6A is a partial cross-sectional view ofan embodiment of insertion guide tube 210, referred to herein atinsertion guide tube 610. As can be seen, insertion guide tube 610includes an anti-twist section 620 formed at the distal end of the guidetube. Anti-twist section 320 is contiguous with the remaining part ofguide tube 610. Guide tube 610 has a lumen 640 which, in proximalsection 624 has a vertical dimension 626, and an distal anti-twistsection 620 has a smaller vertical dimension 634 described below. Thevertical dimension of lumen 640 decreases from dimension 626 todimension 634 due to a ramp 648 at the proximal end of anti-twistsection 642.

Anti-twist section 620 causes a twisted electrode assembly travelingthrough guide tube 610 to return to its un-twisted state, and retainsthe electrode assembly in a straight configuration such that theorientation of the electrode assembly relative to the insertion guidetube 610 does not change.

As shown in FIG. 6C, electrode assembly 145 has a rectangularcross-sectional shape, with the surface formed in part by the surface ofthe electrode contact, referred to herein as top surface 650, and theopposing surface, referred to herein as bottom surface 652, aresubstantially planar. These substantially planar surfaces are utilizedin embodiments of the insertion guide tube described herein.

Tube wall 658 in anti-twist section 620 has surfaces 644 and 646 whichextend radially inward to form an anti-twist guide channel 680.Specifically, a superior flat 644 provides a substantially planar lumensurface along the length of section 620. As shown best in FIGS. 6A, 6B,and 6D, superior flat 644 has a surface that is substantially planar andwhich therefore conforms with the substantially planar top surface 650of electrode assembly 145. Similarly, inferior flat 646 has a surfacethat is substantially planar which conforms with the substantiallyplanar bottom surface 652 of electrode assembly 145. As shown in FIG.6D, when a distal region of electrode assembly 145 is located inanti-twist section 620, the surfaces of superior flat 644 and inferiorflat 646 are in physical contact with top surface 650 and bottom surface652, respectively, of the electrode assembly. This prevents theelectrode assembly from curving, as described above.

FIG. 7 depicts an exemplary embodiment of a cochlear electrode arrayinsertion guide 700. In an exemplary embodiment, the insertion guide 700corresponds to that of the insertion guide 200 detailed above, with theexception of the addition of acoustic stimulation generator 704, and themodifications to the tool so as to support the generator and theassociated components thereof (e.g., electrical leads 706 (only the“distal” portion of the lead (distal relative to the tool 800) isdepicted, the “break' being conceptual), etc.—more on this below).Accordingly, FIG. 7 depicts a cochlear electrode array insertion guidecomprising an array guide (e.g., the insertion guide tube (210 of FIG.2)) and an active functional component (e.g., generator 704). Someadditional details of some exemplary functional components, includingsome exemplary active functional components, will be described ingreater detail below. However, it is briefly noted at this time that notall embodiments of the cochlear electrode array insertion guide includean intracochlear portion. In this regard, FIG. 7 depicts a tool 700 thatincludes an intracochlear portion 710. This is the portion to the rightof stop 204/the portion on the distal side of stop 204 (distal relativeto the entire insertion guide). Conversely, FIG. 8 depicts a tool 800that does not include an intracochlear portion. Instead, stop 204 isconfigured to be placed against the outside of the cochlea such that thepassageway through the tool through which the electrode array is passedis aligned with the pertinent window and/or cochleostomy such that noparts of the tool 800 enters the cochlea.

It is noted that while the teachings detailed herein with respect toextra functionality of the insertion guide are based on the insertionguide detailed above with respect to FIGS. 5A-6D, these teachings can beapplicable to other types of insertion guides. Indeed, as will bedetailed below, some embodiments of the insertion guides do not have anintracochlear portion at all. Accordingly, the teachings above withrespect to FIGS. 5A-6D serve as but one example of an insertion guidethat the following teachings can be utilized in conjunction therewith.

With reference back to FIG. 7, the exemplary active functional componentcan be an acoustic stimulation generator, as noted above. In anexemplary embodiment, the embodiment of FIG. 7 (or FIG. 8) enables themiddle ear to be bypassed so as to provide a source of acousticstimulation in an intraoperative ECoG measurement. In this regard, thestimulation generator 704 can be an extra-cochlea bone conductionactuator positioned such that, when the insertion guide is utilized wheninserting the electrode array into the cochlea, the acoustic signalgenerator 704 is pressed against the cochlear promontory, round window,or cochleostomy during insertion. In an exemplary embodiment, theproximity of the acoustic stimulation generator 704 to the cochleaenables such to be utilized as an acoustic stimulation source duringintraoperative ECoG measuring. In an exemplary embodiment, the acousticstimulation generator 704 is a bone conduction device as detailed above.In an exemplary embodiment, the acoustic stimulation generator 704 is anelectromagnetic actuator that is configured to vibrate when subjected toa current via the electrode lead 706. Alternatively, in an exemplaryembodiment, the acoustic stimulation generator is a piezoelectricactuator that is configured to vibrate when subjected to a current viathe electrode lead 706. In these embodiments, these actuators can beactuated for a bone conduction device, as noted above. That said, insome alternate embodiments, the acoustic stimulation generator can be aspeaker. Element 704 can be any device that can enable stimulationhaving utilitarian value for an ECoG measurement.

The embodiments of FIGS. 7 and 8 are such that the generator 704 abutsthe outside of the cochlea during use so as to establish physicalcontact with the outside of the cochlea. FIG. 9 depicts an exemplaryscenario of use, where element 910 is the wall of the cochlea thatseparates the middle ear cavity from the inner cavity. In an exemplaryembodiment, generator 704 abuts the cochlear promontory. In an exemplaryembodiment, generator 704 abuts the round window and/or oval window.With respect to the “and/or” it is noted that while the embodimentsdepicted herein indicate a single generator, in alternative embodiments,two or more generators can be utilized in an array such that onecontacts the oval window and the other contacts the round window. In anexemplary embodiment, these generators can operate out of phase suchthat a first generator depresses the round window while a secondgenerator provides no force against the oval window, and then the secondgenerator depresses the oval window while the first generator providesno force against the round window. An exemplary embodiment of astructure configured to operate in such a manner or a variation thereofis detailed in U.S. patent application Ser. No. 15/159,335, entitled“Implantable Hearing Prosthesis With Dual Actuation” filed on May 19,2016, to the inventor Joris Walraevens. Any force generator/vibrationgenerator that can establish stimulation to enable ECoG measurement canbe utilized in at least some exemplary embodiments.

In any event, it is again noted that the generator can be locatedanywhere on the guide that the generator can have utilitarian value withrespect to establishing stimulation to enable ECoG measurements. In anexemplary embodiment, the generator can be located such that, duringuse, the generator is not necessarily in direct contact with the cochleaproviding that such has the aforementioned utilitarian value withrespect to generating stimulation enabling ECoG measurement.

While the embodiments detailed above have focused on the generator beinglocated entirely outside the cochlea (e.g., entirely inside the middleear), in an alternative embodiment, the generator is located inside thecochlea during use. FIG. 10A depicts an exemplary insertion regimeutilizing exemplary electrode array insertion guide 1000 where thegenerator 704 is located entirely in the inner cavity (in the cochlea)when the insertion guide is fully inserted into the inner ear cavity.Still further, FIG. 10B depicts an exemplary insertion regime utilizingexemplary electrode array insertion guide 1100 where the generator islocated in the wall that separates the middle ear cavity from the innerear cavity when the insertion guide is fully inserted into the inner earcavity. In an exemplary embodiment, a portion of the generator 704 islocated in the middle ear cavity, and another portion of the generator704 is located in the wall 910 and/or in the inner cavity when theinsertion guide 1100 is fully inserted into the cochlea. In an exemplaryembodiment, the guide is such that the entire generator 704 is locatedin the wall 910 (i.e., in the hole through the wall) when the insertionguide 1100 is fully inserted into the inner ear cavity. That is, no partof the generator is located in the middle ear cavity where the inner earcavity (where, for the purposes of this paragraph only, the volumecorresponding to the hole that is formed in the cochlea so that thearray can pass from the middle ear cavity to the inner ear cavity isneither in the middle ear cavity nor in the inner ear cavity). In anexemplary embodiment, the guide is such that a portion of the generator704 is located in the wall 910 when the insertion guide 1100 is fullyinserted into the inner ear cavity, and a portion of the generator islocated in the inner ear cavity when the insertion guide is fullyinserted into the inner ear cavity.

FIG. 11 depicts an exemplary cross-section of an exemplary insertionguide where the frame of reference is seen relative to the stop 204, andthe distance between the closest service of the stop 204 and thegenerator 704 is greater than the thickness of the wall of the cochleabetween the middle ear cavity in the inner ear cavity. Thus, in thisexemplary embodiment, the entire generator 704 is located entirelywithin the inner ear cavity when the insertion guide is fully insertedinto the inner ear cavity.

As can be seen in this exemplary embodiment, the generator 704 islocated or otherwise embedded in the tube wall 658 of the insertionguide. In the end exemplary embodiment depicted in the figure, thegenerator 704 is located in the proximal section 624 of the insertionguide tube 610. That said, in an alternative embodiment, the generator704 can be located in the anti-twist section 620. The generator can beembedded anywhere within the insertion guide that can enable theteachings detailed herein and/or variations thereof. While theembodiment depicted in FIG. 11 shows only one generator 704, in analternate embodiment, two or more generators can be located in the wall658 or otherwise embedded in the wall 658 such that two or moregenerators are located inside the cochlea when the guide is fullyinserted in the cochlea.

FIG. 12A depicts an alternate embodiment where the generator 1204, whichcan correspond to any of the generators detailed herein or any othergenerator for that matter that can have utilitarian value with respectto enabling the teachings detailed herein, is located on the outside oftube wall 658. As can be seen, lead 706 leads from the outside of theinner ear cavity/from the guide handle section into the inner ear cavityto the actuator 1204. In the embodiment depicted in FIG. 12A theactuator is streamlined so as to not interfere or otherwise enablerelative ease of insertion of the proximal section 624 of the guide intothe cochlea.

While the embodiment of FIG. 12A depicts the generator located entirelyon the outside surface of tube wall 658, in an alternate embodiment, aportion of the generator can be located or otherwise embedded in thetube 658, and another portion of the generator can be proud of the tubewall 658, as can be seen with respect to generator 12104 in FIG. 12B.Still further, FIG. 12C depicts an exemplary embodiment where a cavityis located in tube wall 658, and a generator 122104 is located withinthat cavity. In some embodiments, the generator is not proud of theouter tube wall surface, and in some embodiments, the generator is proudof the outer tube wall surface. In an exemplary embodiment, the areaaround the generator can be filled with another material so as toestablish a smooth outer wall.

FIG. 13 depicts another exemplary embodiment, where the generator 1304is embedded in the tube wall 658, but is in vibratory communication witha band 1305 that extends about the tube wall 658. In an exemplaryembodiment, the generator 1304 vibrates when subjected to an electricsignal via the leads 706, and there are vibrations conducted via aconductor, such as a piece of metal or the like, to the band 1305. In anexemplary embodiment, the band 1305 can be a titanium band. When thevibrations are conducted to band 1305, the band will vibrate.

While the embodiments detailed above have been directed towards thescenario where the generator is located within the cochlea when theinsertion guide is fully inserted in the cochlea, in an alternateembodiment, the generator 1404 is located entirely outside the cochleawhen the guide is fully inserted in the cochlea, and a conductive pathleads to a component that is located inside the cochlea when the guideis fully inserted in the cochlea that vibrates upon actuation orotherwise energize men of the generator. This can be seen in FIG. 14,where element 1404 is the generator, element 1320 is a vibratoryconductive component (e.g., a piece of metal, such as a wire or a tubeembedded in the tube wall 658) that conducts vibrations to the band1305. In an exemplary embodiment of such a conductive element isdisclosed in U.S. patent application Ser. No. 12/957,085, entitled“Hearing Prosthesis Having A Flexible Elongate Energy TransferMechanism,” to inventor Peter B. J. Van Gerwen, filed on Nov. 30, 2010.

FIGS. 15 and 16 present an alternate embodiment where the generator 1504is located entirely outside the cochlea when the guide is fully insertedin the cochlea. Here, generator 1504 is in fluid communication with adiaphragm 1505 via conduit 1520. The generator pulses so as to variablyincrease and/or decrease the pressure within the conduit 1520, whichcorresponds to an expansion and/or contraction of diaphragm 1505. FIG.15 depicts the diaphragm 1505 in the contracted state, and FIG. 16depicts the diaphragm 1505 in the expanded state. As will be understood,expansion and/or contraction of the diaphragm at a sufficient frequencywith a sufficient magnitude will cause waves of fluid motion within thecochlea, and thus will provide the stimulus for an ECoG measurement.

FIG. 17 depicts an exemplary embodiment of the insertion guide where thegenerator 704 can be located such that it is in the hole in the wall 910of the cochlea when the guide is fully inserted into the cochlea. It isnoted that while the embodiment of FIG. 17 depicts the generatorembedded in the wall 658, any of the other embodiments detailed hereinwith respect to the location of the generator can be applicable to theembodiment of FIG. 17. It is noted that while the embodiment of FIG. 17presents the location of the generator 704, in an alternativeembodiment, the location of the output component (e.g., band 1305,diaphragm 1505, etc.) alone or in combination with the generator can belocated in hole in the wall 910 of the cochlea through which the guideis inserted when the guide is fully inserted into the cochlea.

FIG. 18 depicts another exemplary embodiment where the generator 704 islocated on the outside of the insertion guide tube on the proximal sideof the stop 204. In an exemplary embodiment, a vibrationally conductivepath of material different than that made up of the tube can extend fromthe generator 704 to a location inside the cochlea (e.g., concomitanttaunts with the embodiment of FIG. 14, etc.). Still further, theembodiments of FIGS. 15 and 16 can be practiced except where thegenerator is located outside the insertion guide tube. Note also thatwhile the embodiments depicted in FIGS. 14, 15, and 16 utilize acomponent that establishes a vibrational path from the generator to theoutput component that is of a different material than that of theinsertion guide tube (e.g., a wire or the like made of metal, the fluidfilled tube, etc.), in an alternate embodiment, the material of theinsertion guide tube itself provides the medium for the vibrations to betransferred from outside the cochlea to inside the cochlea. Thisembodiment is depicted in FIG. 18.

It is noted that the embodiments detailed above can enableintraoperative ECoG measurements without a functioning middle-ear, suchas a functioning middle ear that is utilized to relay acousticstimulation from an in-the-ear receiver to the cochlea. In an exemplaryembodiment, this can have utility with respect to recipients with middleear infections and/or pediatric cochlear insertions or combinedconductive/sensorineural hearing loss.

In an exemplary embodiment, the generators detailed herein areconfigured to output stimulation no more than 50 dBs, no more than 55dBs, no more than 60 dB, no more than 65 dB, no more than 70 dB, no morethan 75 dB, no more than 80 dB, no more than 85 dBs, or no more than 90dB, or any value or range of values therebetween in 1 dB increments (nomore than 82 dBs, no more than 84 dBs, a range from 50 dBs to 87 dBs).In an exemplary embodiment, the output of the generator cannot outputanymore output than the aforementioned values.

In view of the above, it is to be understood that in an exemplaryembodiment, there is an electrode array insertion guide, such as by wayof example only and not by way of limitation, those detailed above,wherein the insertion guide comprises an assembly configured to providedirect array insertion functionality and ancillary array insertionfunctionality to a user thereof. The direct array insertionfunctionality is just that, the functionality of inserting an electrodearray into the cochlea. The ancillary array insertion functionality is afunctionality having utilitarian value related to the insertion of thearray in the cochlea. In view of the above, an exemplary ancillary arrayinsertion functionality of the guide enables ECoG measurement. As willbe understood from the above, in an exemplary embodiment, exemplaryguides include an extra-cochlea bone conduction actuator system, and theancillary array insertion functionality is output of vibrations directlyto the cochlea by the system. By “output of vibrations directly to thecochlea,” it is meant that the output is provided to the wall of thecochlea separating the inner cavity from the middle ear cavity (e.g.,output directly to the cochlear promontory), that the output is providedin the hole in the wall of the cochlea/passageway from the middle ear tothe inner ear, and/or inside the cochlea.

Still further, in view of the above, it can be seen that in an exemplaryembodiment, there is a device, comprising a cochlear implant electrodearray insertion guide having a plurality of functional capabilities.While two of the functionalities detailed correspond to that of anelectrode array support and providing an acoustic stimulation for anECoG measurement, another exemplary functionality is that of an ECoGelectrode. In this regard, in an exemplary embodiment, there is anelectrode array insertion guide comprising an ECoG electrode. Alongthese lines, FIG. 7 depicts an exemplary embodiment of a cochlearelectrode array insertion guide 1900. In an exemplary embodiment, theinsertion guide 1900 corresponds to that of the insertion guide 200detailed above, with the exception of the addition of electrode 1904,and the modifications to the guide so as to support the electrode andthe associated components thereof (e.g., electrical leads, etc.—more onthis below). Accordingly, FIG. 19 depicts a cochlear electrode arrayinsertion guide comprising a first functionality (the array guide—theinsertion guide tube (210 of FIG. 2)) and a second functionalityfunctional (an ECoG electrode—the electrode 1904).

Again, not all embodiments of the cochlear electrode array insertionguide include an intracochlear portion. In this regard, FIG. 19 depictsa guide 1900 that includes an intracochlear portion 710. This is theportion to the right of stop 204/the portion on the distal side of stop204 (distal relative to the entire insertion guide). Conversely, FIG. 20depicts a guide 2000 that does not include an intracochlear portion.Instead, stop 204 is configured to be placed against the outside of thecochlea such that the passageway through the guide through which theelectrode array is passed is aligned with the pertinent window and/orcochleostomy such that no parts of the guide 2000 enters the cochlea.

FIG. 21 depicts another exemplary embodiment of an insertion guide 2100,where the electrode 1904 is mounted in the intracochlear portion/on theintracochlear portion. It is briefly noted that while the embodimentsdepicted in the FIGs. depict the electrode 1904 as being partiallyembedded in the body of the insertion guide, in some alternateembodiments, the electrode can be fully embedded in the body of theinsertion guide while in other embodiments, the electrode can be fullyproud of the body of the insertion guide. Any arrangement of theelectrode that can enable the teachings detailed herein can be utilizedin at least some exemplary embodiments.

FIG. 22 depicts another exemplary embodiment of an insertion guide 2200,where there is an electrode 1904 located on the stop 204, and thusrepresenting an extra cochlear electrode when the guide 2200 is fullyinserted, and an electrode 1905 located on the intracochlear portion ofthe guide. Thus, exemplary embodiments can include two or moreelectrodes that are part of the insertion guide.

Note also that while the embodiments depicted above have been describedin terms of utilizing a ball electrode, in some alternate embodiments,other types of electrodes can be utilized. To this end, FIG. 23 depictsan exemplary insertion guide 2300 that includes a band electrode 2304 inthe intracochlear portion of the guide (which can be slit in embodimentswhere the insertion tube is split, which split facilitates removal ofthe insertion guide after insertion of the electrode array into thecochlea. Any type of electrode that can enable the ECoG measurements canbe utilized in at least some exemplary embodiments.

As will be described in much greater detail below, the electrodes 1904and 1905 and 2304 are so-called measurement electrodes that are utilizedin an ECoG system. Corollary to this is that at least some exemplaryembodiments of insertion guides include so-called reference electrodesor return electrodes. To this end, FIG. 24 depicts an exemplaryinsertion guide 2400, which includes a measurement electrode 1904mounted on the stop 204, and a reference electrode 2404 mounted on aflexible support 577. In an exemplary embodiment, when the insertionguide is fully inserted into the cochlea (i.e., the stop 204 hits theouter wall of the cochlea at the cochleostomy), and positioned at theproper angular orientation (about the longitudinal axis of the guide),the reference electrode 2404 is applied against tissue of the recipientat a proper location (e.g., in the middle ear cavity) underneath theskin of the recipient owing to the fact that the anatomy of the humanbeing is generally the same from one human being to the other. While theexemplary embodiment depicted in FIG. 24 depicts the reference electrode2404 being located at the “bottom” of the insertion guide, the referenceelectrode 2404 can be located at other places. Note also that while theembodiment depicted in FIG. 24 depicts the support 577 position at aboutthe midway portion of the guide, in other embodiments, the support 577,and thus the reference electrode 2404, can be positioned closer to thedistal end or closer to the proximal end. Note also that while theembodiment depicted in FIG. 24 depicts only a single referenceelectrode, in an alternate embodiment, two or more reference electrodescan be utilized. Any arrangement of reference electrodes that can haveutilitarian value can be utilized in at least some exemplaryembodiments.

FIG. 25 depicts an alternate embodiment of an insertion guide 2500 wherea support structure 577 extends from the top portion of the guide 2500and supports a ball electrode 1904 (or some other type of electrode)away from the stop 204. In an exemplary embodiment, this can haveutilitarian value with respect to positioning the ball electrode 1904against an outside of the cochlea at a location in direct contact to theround window and/or the oval window when the insertion guide is fullyinserted in the cochlea. In an alternative embodiment, this can haveutilitarian value with respect positioning the ball electrode such thatthe ball electrode is not in direct contact with the round window and/orthe oval window when the insertion guide is fully inserted into thecochlea. Such can also have utilitarian value with respect to placingthe electrode 1904 against the outer wall of the cochlea at a locationaway from the cochleostomy.

In this exemplary embodiment, structure 577 is a flexible structure thatis configured to flex so as to accommodate the fact that the insertionguide 2500 can be utilized differently in some scenarios and/or toaccommodate the fact that human physiological structure can slightlyvary from recipient to recipient. In an alternate embodiment, structure577 is a structure that is configured to press the electrode 574 againstthe outside of the cochlea so as to hold the electrode 574 against thetissue as a result of spring forces or the like. Indeed, in an exemplaryembodiment, structure 577 can be a spring.

FIG. 26 depicts another exemplary embodiment where a support structure578 supports a spring-loaded plunger 579 that supports the electrode1904 at the end of a spring-loaded cylinder. In this embodiment, plunger579 is configured to accommodate the movements of the guide 2600relative to the cochlea, such that the ball electrode 1904 is positionedagainst the outer wall of the cochlea prior to full insertion of theguide 2600 into the cochlea (i.e., prior to the stop 204 contacting theoutside wall the cochlea). In this regard, the configuration of theplunger 579 is such that the force applied to the electrode 1904 againstthe tissue of the recipient is always greater than any force that wouldpull the electrode 574 away from the tissue resulting from the movementof the guide slightly away from the cochlea during use of the guide.Indeed, in an exemplary embodiment, there can be utilitarian value withrespect to practicing ECoG measurements without the guide 2600 fullyinserted into the cochlea, if only so as to provide relief to thesurgeon (if the surgeon is not constantly applying a force against thecochlea, his or her hands will not be as stressed relative to that whichwould be the case if the surgeon had to constantly apply force againstthe cochlea).

Indeed, corollary to the scenario where ECoG measurements are taken in aregime where the insertion guide is not fully inserted into the cochlea,an exemplary embodiment entails taking ECoG measurements utilizingelectrodes of the insertion guide where the insertion guide iscompletely outside the cochlea. FIG. 27 depicts an exemplary embodimentof such an insertion guide, where the tip of the insertion guideincludes a reference electrode 2704. In an exemplary scenario of use,the insertion guide 2700 is completely withdrawn from the cochlea, andthe tip is placed against the outer wall of the cochlea, such as on thecochlear promontory, and then ECoG measurements are taken utilizing thereference electrode 2704 as the reference electrode. FIG. 28 depicts anexemplary scenario of utilization of the embodiment of FIG. 27, wherethe electrode 2704 is placed against the outer wall 910 of the cochlea,subsequent to full implantation of the electrode array 2720. Is alsonoted that an exemplary scenario of use can be such that the insertionguide 2700 is utilized for ECoG measurements before the electrode array2720 is inserted into the cochlea, as well as after the electrode array2720 is inserted into the cochlea.

It is noted that embodiments of the insertion guide having the acousticstimulation generator can be combined with embodiments of the insertionguide having the measurement electrode. To be clear, any feature of anyembodiment detailed herein can be combined with any other feature of anyembodiment detailed herein, unless otherwise noted. To this end, FIG. 29depicts an exemplary insertion guide that has a plurality offunctionalities beyond the functionality of inserting the electrodearray into the cochlea. In particular, as can be seen, the insertionguide 2900 includes an acoustic stimulation generator 704 and areference electrode 1904. In this exemplary embodiment, lead 706 fromthe generator 704 and lead 2406 from the electrode 1904 lead to ajunction box in the hand guide, and then a lead/a plurality of leadsextends to a connector 2410. The connector 2410 can be connected to anECoG system as will be described below.

FIG. 30 depicts an alternate embodiment of an insertion guide 3000 wherethe generator 704 is located closer to the distal end. This can haveutilitarian value with respect to providing vibrations to the cochleawhile the insertion guide is positioned as seen in FIG. 28 in that thegenerator is located closely to the tip of the insertion guide. In anexemplary embodiment, a material that is conducive to vibrations canextend from the generator 704 to the tip, or to the electrode 2704. Thatsaid, in an alternate embodiment, the housing of the generator 704 canabut or otherwise be in contact with the backside of the electrode 2704.In an exemplary embodiment, the vibrations are transferred from thegenerator 704 directly or indirectly to the electrode 2704, and then tothe wall of the cochlea 910 so as to provide stimulation for an ECoGmeasurement.

That said, while the embodiment depicted in FIG. 30 has the generator704 located in the intracochlear portion, consistent with theembodiments detailed above, an exemplary embodiment, the generator 704can be located in the portion of the guide outside the cochlea when theguide is fully inserted into the cochlea, and the guide itself oradditional material conducive to establishing a path forvibrations/conducive to conducting vibrations can extend from thegenerator to the electrode 2704. Thus, an exemplary scenario of useentails placing the tip of the guide 3000 on the outside wall of thecochlea, such as the cochlear promontory, such as that depicted in thescenario of use of FIG. 28, and activating the generator 704 so as toprovide acoustic stimulation to the cochlea, and utilizing the electrode2704 is part of a measurement electrode of an ECoG system.

Consistent with the teachings detailed above that embodiments caninclude two or more generators 704 and two or more electrodes, FIG. 31depicts an exemplary insertion guide 3100 that includes such dualcomponents. In an exemplary scenario of use, the generator 704 mountedon the stop and the electrode 1904 can be utilized during a first ECoGmeasurement where the insertion guide is fully inserted into thecochlea. In another exemplary scenario of use, the generator 704 mountedon the intracochlear portion of the guide and the electrode 2704 on thetip of the guide can be utilized during a second ECoG measurement wherethe guide is completely out of the cochlea. To be clear, someembodiments can utilize one generator for both scenarios, and someembodiments can utilize one electrode for both scenarios. For example,in at least some exemplary embodiments, the electrode 2704 can beutilized for both scenarios. Still further, an exemplary scenario couldutilize the generator 704 mounted on the stop for both scenarios, suchas in an embodiment where a sufficiently conductive path is present forvibrations to travel between the generator 704 to the electrode 2704.

While the embodiments detailed above have depicted the generator and theelectrodes as static components relative to the rest of the guide(static in the sense that the overall positions thereof do not changerelative to the guide/changes in the position of the guide change thepositions of the electrodes and generators), FIG. 32 depicts analternate embodiment where a stimulation generator 7704 is mounted orotherwise adjustable in a manner somewhat analogous to a switchblade. Inthis regard, generator 704 is mounted on a beam 3205 that is hingedlysupported/connected to the guide 3200. In an exemplary scenario of use,the insertion guide 3200 is utilized to insert the electrode array inthe configuration depicted in FIG. 32. In an exemplary scenario of use,ECoG measurements are taken utilizing the guide 3200 in theconfiguration of FIG. 32 while the guide is fully inserted into thecochlea. For example, generator 704 can be utilized in conjunction withelectrode 1904. Still further, providing there is sufficient vibratoryconduction between the generator 704 and the electrode 2704, guide 32 isutilized in the scenario of use detailed above with respect to FIG. 28.That said, in another exemplary scenario of use, the generator 7704 ismoved by articulating the beam 3205 about the hinge so that thegenerator 7704 is positioned as seen in FIG. 33. In an exemplaryscenario of use, the electrode 2704 is positioned against the outer wallof the cochlea, and the generator 7704 is also positioned against theouter wall of the cochlea, and ECoG measurements are taken utilizing thegenerator 7704 as the source of acoustic stimulation.

Thus, embodiments of the electrode array insertion guides can includeembodiments where the additional functional components can be moved inand out of position on an as-needed basis.

Note that the embodiment of FIG. 32 is but exemplary. In an alternateembodiment, such as that seen in FIG. 34, the generator 7704, supportedby telescoping boom 3405, telescopes out of the guide 3300 (FIG. 35depicts the generator 7704 telescoped out of the guide).

Note that in an alternate embodiment, the boom 3405 and the generator7704 can be fixed to the guide in a manner analogous to fixing a bayonetto a rifle. In an exemplary scenario use, the various actions detailedherein are executed, and then subsequent withdrawal of the guide fromthe cochlea, boom 3405 is attached to the guide, and then ECoGmeasurements are commenced utilizing the generator 7704. In an exemplaryembodiment, a connector can be provided at the base or another locationof the boom 3405 so as to place the generator 7704 into electricalcommunication with a lead assembly in the body of the guide so that uponconnection of the boom 3405 to the guide, electrical signal can beprovided to the generator 7704 so as to actuate the actuator therein soas to cause the generator 7704 to vibrate or otherwise outputstimulation so that in ECoG test can be executed.

In an exemplary embodiment, utilization of the guide of FIG. 29 is suchthat the electrode can be positioned adjacent the round windowniche/cochleostomy so as to function as a sense electrode for an extracochlear ECoG system. To this end, FIG. 36 depicts a functional blockdiagram of a system 544, at least part of which can be included in theinsertion guide. More specifically, FIG. 36 depicts a functional blockdiagram of a system 544 usable with the insertion guides detailed hereinand/or variations thereof, system 544 includes a communications unit 532that receives and/or transmits signals to communicate with a remotecomponent, such as a data recorder. In an exemplary embodiment, theoutput of unit 532 is transferred to connector 2410 of FIG. 29. In anexemplary embodiment, receiver/transmitter unit 532 is configured toreceive signals from a remote unit so that the system 544 can utilizethose signals so that the system 544 can utilize those signals toimplement the telemetric operations/the ECoG and methods detailed hereinand/or variations thereof as will be described in greater detail below.The unit 532 is also configured to transmit signals to the remote unitso as to transmit the telemetric information gathered by the system 544as will be detailed below. As can be seen from FIG. 36, communicationsunit 532 is in two-way communication with stimulation arrangement 704,which corresponds to any of the generators detailed herein and/orvariations thereof. FIG. 36 depicts two-way communication between units532 and 704. That said, in an alternate embodiment, there is onlyone-way communication between these two components. (It is noted at thistime that any disclosure herein of one-way communication corresponds toan alternate disclosure of two-way communication, and vice versaproviding that the art enables such, unless otherwise specificallynoted.) The communication between unit 532 and unit 704 permits thestimulation arrangement 704 to output energy to evoke a hearing perceptbased on received signals by the communications unit 532 to evoke ahearing percept according to the teachings detailed above.

Still with reference to FIG. 36, system 544 includes a test unit 560that can correspond to a processor or the like configured to implementtesting according to the teachings detailed herein and/or variationsthereof. It is noted that while the test unit 560 is depicted as beingseparate from the guide 2900 (the portions inside the dashed line), insome alternate embodiments, the units are integral with one another. Anyarrangement that can enable the teachings detailed herein and/orvariations thereof to be practiced can be utilized in at least someexemplary embodiments. As can be seen, test unit 560 is in two-waycommunication with the communications unit 532 via signal line 636.

Test unit 560 is also in communication with one or more of measurementelectrodes 1904 and, optionally, 1904X (and others not shown, in someembodiments) via communication with unit 532 which is in turn in signalcommunication with those electrodes via signal line 570, and is also incommunication with one or more reference electrodes 580 via signal line680, where reference electrode 580. (While the embodiment of FIG. 36depicts the reference electrode as not being part of the insertionguide, in an alternate embodiment, reference electrode can be part ofthe insertion guide as detailed above, and, in an exemplary embodiment,signal line 680 thus can extend to unit 532 in a manner analogous tosignal line 570.

It is noted that while some embodiments depict the reference electrode580 as being separate from the implant, in an alternate embodiment, thereference electrode is part of the implant or otherwise supported by thehousing that houses, for example, the receiver/stimulator unit of thecochlear implant. In this regard, in an exemplary embodiment, theinductance coil of the cochlear implant can be utilized to communicatewith the reference electrode. Accordingly, in an exemplary embodiment,signal line 680 entails an inductance coil communication system locatedbetween electrode 580 and unit 560. Any placement of the returnelectrode 580 that can enable the teachings detailed herein and/orvariations thereof can be utilized in at least some exemplaryembodiments.

It is briefly noted that some embodiments according to the teachingsdetailed herein are practiced without any electrodes located in thecochlea. That is, all electrodes are located outside the cochlea and arethus extra cochlear electrodes. Thus, an exemplary embodiment entailsexecuting some or all of the teachings detailed herein and/or variationsthereof in a noninvasive manner with respect to the cochlea (althoughembodiments will include an invasive process or device associated withthe recipient in general). In an exemplary embodiment, the electrodesare arrayed or otherwise positioned so as to measure or otherwise detectsignals indicative of the cochlear function.

FIG. 37 presents additional details of test unit 560. It is again notedthat the teachings associated with the test unit 560 are exemplary innature, and can be implemented in any manner that will enable theteachings detailed herein. Indeed, the teachings detailed herein arepresented for purposes of compactness and ease of understanding byreferring to a “test unit.” It is noted that one or more or all of thefunctionalities detailed herein associated with the test unit can bedistributed through other portions of the prosthesis. In this regard,any prosthesis that enables the functionality detailed herein can beutilized in at least some exemplary embodiments. With this in mind, anexemplary embodiment includes a measurement system having test unit 560that includes an electrophysiology measurement (EP) device 604, such asan electrocochleography (EC) measurement device, interconnected thereto.The electrophysiology measurement device 604 is configured to measurethe electrical potential(s) associated with the cochlea and/or auditorynerve in response to test signals that are generated by the test unit560 and supplied to the stimulation arrangement 704 (either indirectlythrough unit 532, or, in some other embodiments, where the test unit 560is actually a part of the guide as well, directly to stimulationarrangement 704), where a component of the system generates stimulationsignals based on that output that is utilized to actuate the stimulatorarrangement 704. It is noted that while the embodiments detailed hereinconcentrate on the electrical potential, alternate embodiments can beutilized to measure other features associated with the cochlea and/orauditory nerve. Any measurement of any physiological feature that canenable the teachings detailed herein and/or variations thereof to bepracticed can be utilized in at least some exemplary embodiments.Herein, any disclosure of the measurement of electrical potentials withthe sensation of electrical potentials corresponds to a disclosure ofthe measurement and/or sensation of any electricalphenomenon/characteristics associated with electrophysiology (e.g.,electrocochleography) and/or the disclosure of a measurement and/orsensation of any electrical phenomenon/characteristics associated withelectrophysiological signals that can enable the teachings detailedherein and/or variations thereof (e.g., measurement of higher evokedpotentials (e.g., higher than ECoG)).

In an exemplary embodiment, the measured electrical potential(s) may beoutput as measurement signals by the electrophysiology measurementdevice 604 to the test unit 560 and processed/output to a user to assessvarious features associated with the recipient pre-and/orpost-implantation of the electrode array. The electrophysiologymeasurement device 604 may be provided to measure or otherwisedetect/sense cochlear microphonic, summating potential and/or compoundaction potential of the auditory nerve and the auditory nerveneurophonic in response to the noted test signals. The cochlearmicrophonic, summating potential is the electrical potential generatedat the hair cell level in the cochlea. In some exemplary embodiments,such summating potential has a predeterminable latency range followingstimulation. Further, the summating potential can have, in someexemplary embodiments, a predeterminable durational range (e.g.,directly related to the test signal duration) and predeterminableabsolute amplitude range. Such predeterminable ranges are employed bytest unit 560 in at least some exemplary embodiments to facilitateprocessing of the measured potential values output by electrophysiologymeasurement device 604.

The action potential of the auditory nerve is an electrical responsethat is generated by the cochlear end of the VIII cranial nerve and istypically viewed as representing the summed response of the synchronousfiring of thousands of auditory nerve fibers. That is, the size of theaction potential reflects the number of nerve fibers which are firingsimultaneously. In the absence of adverse pathology, the actionpotential can have a predeterminable latency range (e.g., about 1.30milliseconds to 1.70 milliseconds). Its duration can also have apredeterminable range (e.g., about 0.80 milliseconds to 1.25milliseconds), with a predeterminable absolute amplitude range (e.g.,between about 0.60 millivolts and 3.00 millivolts). Such predeterminableranges can be employed in some exemplary embodiments by test unit 560 tofacilitate processing of the measured potential output fromelectrocochleography measurement device 604. It is noted thatmeasurement signal values corresponding with the measured magnitude ofthe summating potential and/or action potential and/or a ratio thereofcan be extracted and processed by the test unit 560 in at least someexemplary embodiments to assess the interface between the implantabletransducer and middle ear component or inner ear of the recipient, e.g.,the actuator of stimulation arrangement 550. As will be described ingreater detail below, this assessment of the interface is utilized insome exemplary methods to determine whether or not adjustments to theprosthesis can have utilitarian value relative to not making adjustmentsto the prosthesis, etc.

In some embodiments, to enable measurement of the summating potentialand/or action potential, the test unit 560 comprises one or moremeasurement electrodes 1904/1904X. To be clear, an electrocochleographymeasurement electrode can be positioned as part of the insertion guideat a variety of locations, thus permitting that electrode to bepositioned at a variety of locations inside the recipient (as is alsothe case with other types of electrography measurement electrodes).

Referring again to FIG. 37, the test unit 560 can comprise a signalgenerator 606, a reference transmitter 608, a signal processing unit610, a test control processor 612, and a communication unit interface614 that communicates with the communication unit 532 via signal line632. By way of example, the test control processor 612 may providesignals for setting signal generator 606 to output reference signals ata predetermined frequency, or plurality of frequencies across apredetermined range, or a broadband reference signal, e.g., a click. Theoutput reference signals may be provided to the reference transmitter608, which in turn outputs test signals to the particular stimulationarrangement 704 (either directly or indirectly) and the signalprocessing unit 610. The signal processing unit 610 can analyze and/orstore data based on the signals so as to enable an evaluation of theperformance and positioning of the hearing prosthesis and/or aphysiological aspect of the recipient. In an exemplary embodiment, theunit 610 is in communication with a non-transitory computer-readablemedium having recorded thereon, a computer program for executing one ormore or any of the method actions detailed herein associated with theunit 610. In certain applications, it is utilitarian for the testcontrol processor 612 to provide signals to the signal generator 606 tooutput reference signals that are swept across or inherently broadbandto encompass a predetermined frequency range (e.g., a frequency rangethat encompasses a predetermined or determinable resonant frequency ofan implantable stimulation arrangement 704). Any arrangement of testsignals and control regimes that will enable the teachings detailedherein and/or variations thereof to be practiced can be utilized in atleast some exemplary embodiments.

It is briefly noted that while the embodiment of FIG. 36 is presented interms of the test unit 560 being separate from the guide 2900, in someother embodiments, test unit 560 is located in the guide, the test unit560 being in signal communication with the communication unit via anelectrical connector therein and/or via hard wiring between thecomponents. That said, in other embodiments, the test unit 560 caninclude its own communication unit so as to enable communication withthe various components utilized in the system. Note further that in someother exemplary embodiments, wireless communication between one or moreof the components can be utilized. FIG. 38 depicts an exemplaryembodiment where a wireless transmitter/receiver 3810, corresponding tothe communication unit 532, is in wireless communication via a wirelesslink with the test unit 560. Any arrangement that can enable theteachings detailed herein and/or variations thereof to be practiced canbe utilized in at least some exemplary embodiments.

It is briefly noted that while the embodiments presented above have beendescribed in terms of the utilization of the signal generator 606generating a signal, in an alternative embodiment, a signal upon whichthe basis of the telemetric teachings detailed herein are implementedcan be based on a sound that is captured by the sound capture device ofthe hearing prosthesis, whether that be located outside of the recipientin the case of a partially implantable hearing prosthesis or within therecipient in the case of a fully implantable hearing prosthesis.

As noted above, the electrophysiology measurement device 604 provides,in some exemplary embodiments, measured electrical potential values totest unit 560 and/or another device of the prosthesis. Moreparticularly, the measured potential values are provided to the signalprocessing unit 610 in the exemplary embodiment presented in FIG. 37. Inturn, the signal processing unit 610 can process the measured potentialvalues in accordance with preset algorithms. For example, utilizing thestored reference signal information and stored algorithms correspondingwith one or more of the above noted predeterminable ranges, the signalprocessing unit 610 is configured in some embodiments to selectivelyextract the summating potential and/or action potential from themeasured potential values. Still further, the processing unit 610 isfurther configured to process the extracted values (e.g., average thevalues and/or otherwise successively compared these values to determinewhether and/or when a predetermined threshold or maximum value isreached (e.g., thereby indicating a desired interface).

As briefly noted above, in at least some exemplary embodiments, someexemplary insertion guides can include a self-contained ECoG system.FIG. 39 depicts such an exemplary embodiment of an insertion guide 3900.Insertion guide 3900 contains a complete ECoG system. As can be seen,the insertion guide 3900 further includes a reference electrode 2404,which is in signal communication with the electrical leads of the systemvia lead 2416. Lead 39061 extends from the connector to test unit 3960,which can correspond to test unit 560 detailed above. Test unit 3960 isin signal communication with communication unit 3810 via lead 39062.Communications unit 3810 can be in wireless communications with remotedevice 3960. In an exemplary embodiment, the remote device 3960 is adata storage device/data recording device that records the datatransmitted via the communications unit 3810. For example, 3960 can be adesktop and/or a laptop computer having memory therein to record thedata. In an alternate embodiment, device 3960 can be a control unit orthe like, again such as a computer, that can control the ECoG system ofthe guide 3900. That said, in an exemplary embodiment, the guide 3900includes an activation switch or the like so that the ECoG system can beactivated and/or deactivated by the surgeon or other healthcareprofessional.

FIG. 40 depicts an exemplary schematic of the ECoG system 4044 of theguide 3900, or system 4044 is entirely integrated into the guide 3900(e.g., the communication unit 532 and the test unit 3960 are integratedinto the handle of the guide (either in or on the handle)) and theelectrodes and the generator are supported by the guide in accordancewith the teachings detailed herein and/or variations thereof. As can beseen, test unit 3960 is in signal communication with communication unit532 via signal line 636. Through communication unit 532, the test unit3960 can indirectly communicate with the generator 704 and theelectrodes 1904 and 1904X. That said, alternatively and/or in additionto this, test unit 3960 can be in communication with the electrodes viasignal line 570A and with the generator via signal line 636A. Further,the reference electrode 580 can be in communication with thecommunication unit 632 instead of and/or in addition to directcommunication with the test unit 3960. Note also that in an exemplaryembodiment, the reference electrode 580 can be a remote unit that is notpart of the insertion guide. Any arrangement that can enable theteachings detailed herein can be utilized in at least some exemplaryembodiments.

FIG. 41 depicts another exemplary embodiment of an insertion guide thathas a functionality beyond that of an electrode array support/anelectrode array insertion device. Particularly, the embodiment of FIG.41 depicts a portion of the insertion guide tube at the stop 204 where asensor 4101 is located in the wall 658 of the tube, although in otherembodiments, the sensor 4101 is located on the inside wall of the tubeand in other embodiments, the sensor 4101 is located on the outside wallof the tube. In this exemplary embodiment, the sensor is configured tosense or otherwise detect individual electrodes in the array as theypass by the sensor as the electrode array is inserted through the lumen640 into the cochlea, and output a signal via lead 1410 indicative of atleast one of an electrode passing the sensor 4101 or, in a moresophisticated embodiment, the speed of the electrode/electrode arraypassing by sensor 4101. In an exemplary embodiment, the sensor 4101 canbe a sensor that utilizes capacitive sensing. In an exemplaryembodiment, it could be a Hall effect sensor. In some embodiments, thesensor could be a sensor that comes into direct contact with theelectrodes of the electrode array. In an exemplary embodiment, there isa system that receives the signal from lead 1410 and outputs dataindicative of the insertion speed of the electrode. In an exemplaryembodiment, the system can be a personal computer with an algorithm thatanalyzes the signal 4110, and outputs data to the surgeon. Exemplaryoutput can be output by a speaker or the like indicating the speed ofthe insertion of the electrode array. Exemplary output can be output bya visual device indicating the speed of insertion of the electrodearray. Exemplary output can correspond to the speed of insertion, ago/no go data package (e.g., insertion too fast/insertion speed fine).Such can be done via audio and/or visual devices. For example, a greenlight can indicate acceptable speed and a red light can indicate anunacceptable speed. Moreover, the system can be binary. The activationof the light will indicate that the speed is too fast/the audioindication (which could be a buzzer or a tone, etc.) activates when theinsertion speed is too fast. The alternative could also be the case. Thetone and/or light can be activated while the insertion speed isacceptable, and the tone or light is deactivated when the insertionspeed is unacceptable.

FIG. 42 depicts an alternate embodiment, wherein the sensor 4201 is avisual sensor. For example, optics 4202 view the inside of the insertionguide tube 610/view the lumen. Indicia on the array, such as markingsprovided especially for this purpose, or, in an alternative embodiment,the electrodes themselves, can be counted or otherwise detected via thesensor 4201 and thus the speed determined or otherwise deduced. In anexemplary embodiment, the sensor 4201 is a photosensor. In an exemplaryembodiment, the sensor is a CCD. Any arrangement that can be utilized tovisually sense the passage of the array can be utilized in at least someexemplary embodiments.

In an alternate embodiment, sensor 4201 utilizes a sound or a radio waveor the like to detect the passage of the array and deduce the speedthereof. In an exemplary embodiment, a Doppler shift or the like can beutilized. Thus, in an exemplary embodiment, sensor 4201 can generate asound wave and/or a radio wave, and receive the soundwave and/or radiowave. Thus, the sensor can be akin to a sonar sensor and/or a radarsensor.

In an exemplary embodiment, lead 4110 is connected to a processor thatcan determine the speed and/or can utilize the information from sensor4201 or 4101 or any other sensor to determine the insertion depth of theelectrode array. In an exemplary embodiment, the processor can be partof the guide. Indeed, concomitant taunts with the teachings detailedabove with respect to the integrated ECoG system, the guide can includea processor or other device that receives the input from the lead 4110and analyzes that input to output data to the user. Thus, in anexemplary embodiment, the guide can have an output device (e.g., a light(LED, etc.), located on the stop as seen in FIG. 43) that provides theuser with data. A plurality of output devices can be utilized (e.g., twolights, one red/one green, although it is noted that in some alternateembodiments, an LED that can change colors is utilized). In this regard,FIG. 43 depicts an exemplary insertion guide that includes a light 4120.The light is in signal communication with a processor (not shown) vialead 4210. In an exemplary embodiment, the sensor 4201 provides a signalto the processor via lead 4110, and that processor analyzes the signal,and provides output via lead 42102 activate light 4130 to indicateinformation regarding the insertion speed and/or the distance. In anexemplary embodiment, an array of lights is arrayed about the outerperiphery of the stop. In an exemplary embodiment, these lights arevariously activated and/or deactivated to indicate the speed and/or thelocation of the array in an analog and/or a digital manner. Note alsothat while the embodiment presented in FIG. 43 relies on a remoteprocessor remote from the sensor 4102, in an alternate embodiment, thesensor can include processing capabilities and/or can be such that itcan output a signal directly to the lights 4130 and/or a plurality oflights and/or other output devices (speakers—the output could be clickslike a Geiger counter or some other sound that indicates distance and/orspeed, etc.). Indeed, in an exemplary embodiment, the remote processoris not needed.

In an exemplary embodiment, the sensors utilized to monitor the speedand/or location of the array within the lumen 640 utilize or otherwiseimplement capacitive coupling between the electrodes and the array andthe sensor.

While the embodiments depicted in FIGS. 41 and 42 depict a singlesensor, in alternate embodiments, a plurality of sensors are utilized.Indeed, the sensors can be arrayed such that the sensors are located“out of phase” with respect to each other and the electrodes of thearray such that the sensors can be “tripped” more frequently than thatwhich would be the case utilizing one sensor or a sensor having spacingthe same as or greater than the distance between electrodes. This canhave utilitarian value with respect to not having to wait for feedbackfrom only one sensor to determine the speed and/or location of thearray. For example, in an insertion guide having a plurality of sensorslocated out of phase with each other relative to the electrode spacing,an electrode or other indicia on the array can pass the first sensor,and then pass a second sensor, and/or a third sensor, and/or a fourthsensor, etc. prior to another electrode passing the first sensor. Thus,this provides additional data points to deduce the speed and/or locationof the array. Note also that while the embodiments depicted in the FIGs.depict the sensor located at the top of the insertion guide tube, in analternate embodiment, the sensors can be located on the bottom. Such canhave utilitarian value in embodiments where the electrodes are locatedon the bottom of the array as opposed to on the top of the array.

Note also that while the sensors are depicted as being proximate thestop, in alternative embodiments, the sensors can be located elsewhere.Indeed, in an exemplary embodiment, the sensor can be located at the tipor proximate to the tip of the insertion guide. In this regard, thesensor can provide an indication to the surgeon or the like when thearray first leaves the tube. Again, sensors can be arrayed at a numberof locations. Any arrangement of sensors that can enable the teachingsdetailed herein can be utilized in at least some exemplary embodiments.

It is noted that at least some embodiments that utilize the electrode orother devices to measure or otherwise monitor insertion speed and/orinsertion depth do so without measurements of the impedance ofindividual electrodes as the array is inserted into the conductiveperilymph. That is, in an exemplary embodiment, the insertion guide isconfigured so as to monitor insertion speed and/or insertion depthwithout the presence of perilymph between the sensor of the guide (e.g.,electrode) and the electrode array. However, in some alternateembodiments, measurement of either voltage induced in the perilymph dueto stimulation current being passed from one intro cochlear electrodecontact to another, with the impedance and passing current from astimulating contact on the array to a return contact on the sheath,could be used to infer the proximity of a contact passing through thesheath, and thus can be utilized to monitor insertion speed and/orinsertion depth based on the inference the proximity of the contact.

FIG. 44 depicts a portion of an exemplary insertion guide that isconfigured to enable testing for an open circuit between two or moreelectrodes of the electrode array as the array passes through the lumen640. Briefly, component 4401 is made of a conductive material thatessentially “shorts” two electrodes of the electrode array as they passby in contact with the component 4401. As will be detailed below,component 4401 can be a flexible component so as to provide acompressive force on the outside of the electrode array so as toestablish sufficient electrical conductivity between an electrode,component 4401, and another electrode. In general terms, FIG. 45 depictsa quasi-functional diagram of a portion of electrode array 145,depicting electrodes 1, 2, and 3, which are respectively connected toleads 11, 12, and 13, which leads extend from the respective electrodesto the proximal end of the electrode array assembly, and then to areceiver/stimulator thereof. While only three electrodes and three leadsare depicted in FIG. 45, it is to be understood that in at least someembodiments, more electrodes and more leads are present in electrodearray 145. Only three electrodes and only three leads are depicted inFIG. 45 for clarity.

In isolation, without any contact with any outer material other thanair, to test for a short, a source of current is applied to any one ofthe leads 11, 12, or 13. If current is detected (this phenomenon isdescribed generally—in at least some exemplary embodiments, the“detection” corresponds to a given functionality of thereceiver/stimulator that can be telemetrically transmitted andanalyzed—more on this below) at any one of the other leads 11, 12,and/or 13, a determination can be made that a short exists. This isbecause the impedance between the electrodes 11, 12, and 13 should berelatively high (the material connecting the electrodes 148 is typicallymade of silicone). The leads 11, 12, and 13 are insulated from oneanother and from the electrodes other than the respective electrodesassociated with the respective leads.

Conversely, to detect for an open, in the absence of contact with anyother material other than air, because of the high impedance between therespective electrodes, and the aforementioned electrical insulation,there is nothing to close the circuit between a source of electricalcurrent applied to one lead, and a detector (again, this is usedgenerally—more on this below) located at any of the other leads.

Accordingly, in an exemplary embodiment, the apparatus 4401 isconfigured to enable testing for an open circuit between two electrodesby utilizing conductive material that is sufficiently conductive to testfor an open circuit when placed into contact with two or more electrodesof the electrode array 144. In use, component 4401 extends a sufficientdistance into the lumen 640 and has sufficient length such that it cancontact two electrodes as the electrode array passes by component 4401.In an exemplary embodiment, the entire component 4401 is made of arequisite conductive material. In an exemplary embodiment, only aportion thereof is made of the requisite conductive material. By way ofexample only and not by way of limitation, at least the bottom surface(the surface that faces the electrodes/the surface that comes intocontact with the electrodes) can be made of the requisite conductivematerial, or at least coated with the requisite material or otherwisethe requisite material is attached to the interior thereof). In anexemplary embodiment, only a portion of the component 4401 is made ofthe requisite conductive material. Any arrangement that can enable thetesting of an open circuit while electrode array assembly is beingpassed can be utilized in at least some embodiments.

In an exemplary embodiment, the material of the component 4401 and/orother material forming a portion of the component 4401 and/or any othermaterial that enables testing for an open circuit has a “midrange”impedance, or at least enables the establishment of a midrange impedancebetween two or more electrodes, such that both testing for an opencircuit and testing for a short circuit can be implemented. In otherexemplary embodiments, the component 4401 has a relatively high rangeimpedance.

In an exemplary embodiment, the component 4401 is configured to providea controlled impedance between two or more electrodes that will enableat least testing for an open circuit between two electrodes, if not bothtesting for an open circuit and testing for a short circuit between twoelectrodes.

Thus, in an exemplary embodiment, the component 4401 is configured toenable two types of conductivity testing of the electrode array (e.g.,testing for an open circuit and testing for a short circuit) in someembodiments.

FIG. 46 depicts an exemplary conductive apparatus 4622 in the form of anelongate cylinder having a passage 4624 therethrough, wherein thepassage 4624 is sized and dimensioned to receive the electrode array 145therein such that at least two electrodes of the electrode array 145contact the interior walls of the passage 4624 to establish electricalconductivity between the electrodes. In an exemplary embodiment, theconductive apparatus 4622 is configured such that an impedance betweenany two locations on the interior surface of the passage 4624 within adistance corresponding to the distance between two electrodes of theelectrode array 145 that will be inserted or otherwise located withinpassage 4624 is less than about 500 ohms (or any other value that willenable testing for an open circuit between two electrodes—more on thisbelow). In this regard, it is noted that all disclosures of impedanceand related phenomenon detailed herein both correspond to the structurebeing described, and how the structure is arranged or otherwise used.That is, because impedance varies both with respect to distance and withrespect to material type (along with some other features) and it is theresulting impedance that imparts utilitarian value on to the teachingsdetailed herein, as opposed to the specific impedance of a givenmaterial or the like, any disclosure herein regarding materialproperties also corresponds to the functionality of the resultingapparatuses when utilized according to the teachings detailed hereinand/or variations thereof.

FIG. 48A depicts the conductive apparatus 4622 located in the insertionguide tube 610 of the insertion guide. In an exemplary embodiment, theinterior of the conductive apparatus at the ends thereof is rounded soas to provide a smooth interface between the interior wall of the tubewall 658 and the “bump up” that is the interior of conductive apparatus4622. That is, because the interior of conductive apparatus 4622 isproud of the interior wall of the tube wall 658, ramping can be used soas to avoid binding or otherwise catching the electrode array one theedges of the conductive apparatus 4622.

Briefly, the embodiments utilizing apparatus 4622 and variations thereofto “short” two electrodes rely on, in some embodiments, the ability ofthe receiver/stimulator of the cochlear implant to provide an electricalsignal to one of the electrodes and sense a voltage and/or current atthe other of the electrodes. In an exemplary embodiment, a device is ininductance communication (or any other applicable communication formatthat will enable the teachings detailed herein and/or variations thereofto be practiced) with the receiver/stimulator of the cochlear implant soas to communicate data therefrom indicating whether or not an opencircuit is present. Indeed, in an exemplary embodiment, the device thatis in inductance communication with the receiver/stimulator is thedevice that initiates the current to one of the electrodes and the firstinstance. In an exemplary embodiment, the communication can correspondto the communication that transcutaneously takes place between theexternal component 142 and the implantable component 144 vis-à-vis thesystem of FIG. 1. That is, in an exemplary embodiment, the communicationfrom the receiver/stimulator and/or to the receiver/stimulator can beexecuted utilizing techniques that are the same as, or at leastanalogous to, the transcutaneous communication that takes place whilethe cochlear implant 100 is implanted in a recipient fully andcompletely beneath the skin.

FIG. 47 depicts a view looking down the longitudinal axis of theconductive apparatus 4622 (i.e., looking from the left or the right withrespect to the frame of reference of FIG. 46). It is noted that thegeometric shapes presented in these FIGs. are but exemplary. Anyconfiguration that will enable the teachings detailed herein and/orvariations thereof to be practiced can be utilized.

It is further noted that while the embodiment depicted in FIG. 46 andFIG. 47 is depicted as a monolithic component (in an exemplaryembodiment, the entire body 4622 is made from a conductive material, andthus conductive apparatus 4622 is a tube or cylinder of conductivematerial), in an alternative embodiment, the conductive apparatus 4622can be a multilithic component. Indeed, in an exemplary embodiment, thewalls of the passageway 4624 can be coated with a conductive material(e.g., gold), and the remainder of the conductive apparatus 4622 is madeof a relatively nonconductive material (e.g., rubber, silicone, etc.).In this regard, for embodiments where the conductor used to test for theopen circuit is movable in and out of position, the impedance range ofthe conductor can be very low.

It is noted that in an exemplary embodiment, the entire body 4622 and/ora portion thereof (e.g., the portion making up the walls of thepassageway 4624) is a conductive foam or conductive polymer. Typically,this is foam or polymer containing conductive elements (e.g., loadedwith silver, gold, carbon, etc.). This can have utilitarian value withrespect to deforming around the electrode array as the electrode arraypasses through body 4622. Accordingly, such can have utilitarian valuewith respect to contracting as the localized width of the electrodearray relative to body 4622 becomes wider as the electrode array ispassed therethrough during insertion of the electrode array.

FIG. 48A depicts the view of FIG. 47, with the addition of the electrodearray 145 being located in the passage 4624 (the array is shown incross-section). More particularly, the view of FIG. 48 depicts across-sectional view of an electrode array 145 taken at a location whereelectrode 1 is located. FIG. 49 presents FIG. 48A in greater context,which depicts a side view of a cross-section through the conductiveapparatus 4622 with the electrode array 145 located therein.

As can be seen, the electrodes are in contact with the inner surface ofthe passageway 4624. In this embodiment, the contact is sufficient toprovide electrical conductivity from electrode 1 to electrode 2 and/orelectrode 3 such that testing for an open circuit between one of theseelectrodes can be implemented. Corollary to this is that the conductiveapparatus 4622 is configured to maintain the requisite contact to enabletesting for an open circuit between two or more of the electrodes and/orbe placed and held in that configuration for such testing to beexecuted. In an exemplary embodiment, conductive apparatus 4622 is madeof a conductive foam material, wherein an interference fit isestablished between the electrode array 145, and thus the electrodes148, and the inner surface of the passage 4624. In an exemplaryembodiment, the interference fit ensures that sufficient contact will bemade between the inner surface of the passage 4624 and the respectivesurfaces of the electrodes 148. In an exemplary embodiment, the use offoam ensures or otherwise substantially lessens the chance that thearray 145 will be damaged due to contact between the array and theconductive apparatus 4622. This will be described in greater detailbelow.

FIG. 50A presents a functional representation of the functionality ofthe conductive apparatus 622, where hypothetical leads 1010 and 1020 arelocated between electrodes 1 and 2 and between electrodes 1 and 3,respectively. Also shown is hypothetical lead 1030, which is locatedbetween electrodes 2 and 3. These leads place the various electrodesinto electrical conductivity with one another so that testing for anopen circuit can be executed. Also depicted by way of black box formatis a current generator/detector 1040, which is configured to applycurrent to one or more of the leads 11, 12, 13, and detect a current (ifthere is no open circuit) at one or more of the other of leads 11, 12,13. The current generator/detector 1040 is but a functionalrepresentation of the operation of the receiver/stimulator 180 and/or atest device. That said, in some alternate embodiments, currentgenerator/detector 1040 can be an ohmmeter and/or a multimeter, albeitone adapted for the types of voltage and current suitable for testing ofa cochlear electrode array or other array to which the teachingsdetailed herein are applicable.

Briefly, in an exemplary embodiment, a current is applied by currentgenerator/detector 1040 to lead 12. Current generator/detector 1040“looks” for a current at either or both of leads 11 and 13. (In anexemplary embodiment, the insertion guide includes a generatorconfigured to generate current at a programmed amount through lead 12and return it through one or all of the remaining electrodes. In anexemplary embodiment, the guide provides an output indicative of voltagerequired to drive this amount of current. In an exemplary embodiment, ifthe voltage is above a certain threshold, it is deemed an open circuit.Otherwise, it is assumed the current is flowing and thus this circuit isclosed.) Because the conductive apparatus 622 has placed electrode 2into electrical conductivity with electrodes 1 and 3 via hypotheticalleads 1010 and 1030, a current should register at one or both of leads11 and 13 (or only one of the leads if only one of the hypotheticalleads 1010 and 1030 or present) thus indicating that there is no opencircuit between current generator detector 1040 and electrode 2.

Note that by “looking” for a current at two or more leads, the scenariowhere an open circuit exists with respect to one of the other leads,which open circuit could give a “false-negative” with respect to thelead under test can be accounted for in an exemplary embodiment. Forexample, if lead 12 is being tested (or, more precisely, testing for anopen circuit is being performed between current generator/detector 1040and electrode 2), and if only one lead, such as lead 11, was beingutilized for the test, failure to detect a current by currentgenerator/detector 1040 at lead 11 would not necessarily indicate abreak for an open circuit associated with lead 12. This is because lead11 could have failed. However, if a current is detected at lead 13 butnot lead 11, it can be surmised that lead 12 is in proper working order,and lead 11 has experienced a failure mode. That is, it can beextrapolated or otherwise inferred that lead 11 has failed in somemanner (i.e., the open circuit is between current generator/detector1040 and electrode 1). In this regard, exemplary embodiments includealgorithms to more quickly test a plurality of circuits in view of thefact that deductive logic can be utilized when more than two electrodesare placed into electrical conductivity with one another via conductiveapparatus 622.

Note further that to test for a short circuit, the hypothetical leadsare removed from the electrodes (e.g., the electrode array is moved awayfrom conductive apparatus 4622). A current is applied to one or more ofthe leads, and current is looked for at one or more of the other leads.No current (or only specific current—more on this below) should bedetected because the hypothetical leads have been removed.

FIG. 50B presents a hypothetical open circuit scenario, where lead 12has experienced a break at the location indicated by the “X.” In anexemplary method, a current is applied by current generator/detector1040 to lead 12. Current generator/detector 1040 “looks” for a currentat either or both of leads 11 and 13. Because the conductive apparatus4622 has placed electrode 2 into electrical conductivity with electrodes1 and 3 via hypothetical leads 1010 and 1030, a current will notregister at either of leads 11 and 13 (or only one of the leads if onlyone of the hypothetical leads 1010 and 1030 or present) thus indicatingthat there is an open circuit, most likely between current generatordetector 1040 and electrode 2.

Note that by “looking” for a current at two or more leads, it can beimmediately deduced that there is a fault between currentgenerator/detector 1040 and electrode 2 (or a simultaneous fault inelectrodes 1 and 3, which can be addressed by running the test byapplying current at lead 11 and/or lead 13 and looking at lead 12).

In an exemplary embodiment, a common ground impedance (voltage requiredto drive a current between a chosen electrode and all the otherelectrodes shorted together) is measured for each electrode in turn manytimes a second (1, 2, 3 . . . 22, 1, 2, 3 . . . 22, 1, 2, 3 . . . 22,etc.). In this way, whatever electrodes are in contact with the contactsin the sheath, such will show up as low impedance. As the electrodearray advances through the sheath, the low impedance point will traveldown the array from electrode 22 to electrode 1. An open circuit will beevident as the electrodes that never go to low impedance.

Note further that in at least some exemplary methods, the methods arenot executed to detect which lead or which connection is open orotherwise has experienced a failure mode. A determination that there issome failure anywhere will typically be utilitarian in that adetermination can be made in view of the single failure detection thatthe cochlear implant 100 should not be implanted in the recipient atthat time. In an exemplary embodiment, a new cochlear implant 100, suchas a cochlear implant 100 located in a new apparatus 400, will beobtained, and a new round of testing for an open circuit will beexecuted. Such is also the case with respect to detecting whichparticular electrodes are associated with a short circuit.

Note that by way of example only and not by way of limitation, in anexemplary embodiment, a failure mode can correspond to a break in a leadand/or a disconnect between a lead and an electrode, which failure modecan typically result in an open circuit. In an exemplary embodiment,this can occur during shipping of the apparatus 400.

It is further noted that in an exemplary embodiment, instead of a solidor contiguous conductive component that contacts the various electrodes,separate contacts 2262 supported by conductive body that extends betweenthe contacts can be configured to be compressible, at least with respectto the portions on the tip, as can be seen in FIGS. 51A and 51B. In anexemplary embodiment, element 4622 is replaced by conductive apparatus2223. Alternatively, and/or in addition to this, the contacts 2262 canbe supported on a flexible material that flexes to provide space. Thecontact can also be spring loaded in another exemplary embodiment (moreon this below). FIG. 51C depicts another exemplary embodiment of aconductive apparatus 2224 that can be utilized in place of element 4622.Also, in this exemplary embodiment, the conductors 2262 can be locatedonly at the top of the conductive apparatus 2223, instead of all the wayaround, as is the case with the embodiment of FIG. 50C.

It is further noted that variations of the concepts depicted herein canbe implemented to enable the teachings detailed herein. Instead ofutilizing triangular contacts as seen, square contacts can be utilized.Still further, undulating contact surfaces can be utilized such that thecrests of each undulation are in phase with the respective electrodes(e.g., aligned with the centers of the electrodes) of the electrodearray. FIG. 50C depicts an exemplary embodiment of a conductiveapparatus 2224 utilizing a “wavy” contact surface, where contactapparatus 2264 can be seen to have crests that are in phase with theelectrodes of the electrode array 145.

In an exemplary embodiment, any of the teachings of U.S. patentapplication Ser. No. 15/164,789, filed on May 26, 2016, to InventorGrahame Walling, for testing for an open circuit can be incorporatedinto an insertion guide with the requisite modifications to enable opencircuit testing.

While the embodiments detailed above have been directed towards a devicethat shorts two electrodes, an alternate embodiment utilizes anelectrode in the insertion guide to establish a capacitive coupling withthe electrodes of the electrode array as the electrodes of the electrodearray pass by the electrode of the insertion guide. FIG. 52 depicts analternate embodiment of an electrode array insertion tube having anotherfunctionality beyond that associated with supporting and/or guiding theelectrode array into the cochlea. In this regard, element 5201 is anelectrode that is utilized as part of an open circuit testing system.Here, electrode 5201 can establish a capacitive coupling between theelectrodes in the array and the insertion guide in general, and theelectrode 5201 in particular.

As can be seen, electrode 5201 is connected to a lead 5210. In anexemplary embodiment, this lead energizes the electrode with anelectrical current. In an alternate embodiment, this lead provides areturn path in a scenario where the electrodes of the electrode arrayare energized. FIG. 53 depicts an exemplary embodiment of an insertionguide 5300 having the electrode 5301 to establish the capacitivecoupling with the electrodes of the electrode array. Here, electrode5301 is located to the left (proximally) of the stop 204. FIG. 53depicts a cutout view of the tube of the insertion guide showingelectrode 5301 extending into the lumen. Lead 5210 can be seen extendingfrom electrode 5301 to a coupling, to which is connected a lead 53061,which in turn extends to test unit 5360. Test unit 5360 is configured toenergize the electrode 5301 in at least some exemplary embodiments. Insome alternate embodiments, test unit 5360 is configured to receivecurrent from electrode 5301 in the case where the electrodes of thearray are energized. At a minimum, test unit 5360 can be avoltage/energy source, such as an assembly having circuitry to provide acontrolled current at a control voltage to electrode 5301. In anexemplary embodiment, test unit 5360 includes a battery to provide thesource of the current. In an alternate embodiment, test unit 5360 is anassembly having circuitry configured to receive an electrical currentfrom lead 53061 and analyze the current or at least determine whether acurrent is present. Indeed, in an exemplary embodiment, in view of thebinary nature of an open circuit, unit 5360 can be a simple circuit thatenergizes an indicator upon the absence of a received current. By way ofexample, test unit 5360 can include a transistor or the like or someform of relay that is activated and/or deactivated upon the reception ofa current through lead 53061. The activation and/or deactivation of thistransistor or the relay activates an indicator, such as an LED, ordisables the indicator (e.g., turns off the LED) indicating an opencircuit. In an exemplary scenario, upon failure of current from lead53061 reaching test unit 5360, a relay is closed and a circuit isaccordingly closed to illuminate an LED, providing an indication to thesurgeon that an open circuit is present in the electrode array. In anexemplary embodiment, this can be combined with the teachings detailedherein regarding the utilization of the insertion guide to provide anindication or otherwise determine the position of the electrode arrayand/or the speed of insertion. For example, such teachings can becorrelated to the embodiment to test for the open circuit, so that anindication to the surgeon of an open circuit is not provided simplybecause electrode 5301 is not in capacitive coupling with an electrodeof the electrode array, because the electrode 5301 is in betweenelectrodes of the electrode array. Still further, in an exemplaryembodiment, the system of FIG. 53 can be combined with or otherwise usedin conjunction with devices that can indicate whether or not anelectrode of the electrode array is proximate the electrode 5301 orotherwise at a location where capacitive coupling between the electrodecan be established. The system of FIG. 53 is configured so as to onlyprovide an indication of an open circuit when a determination has beenmade that the electrode of the electrode array is proximate theelectrode 5301 or otherwise at a location where capacitive couplingbetween the electrode can be established.

The embodiment seen in FIG. 53 includes communication unit 3810 insignal communication with the test unit 5360 via lead 39062. In anexemplary embodiment, communication unit 3810 can be the communicationunit detailed above. As can be seen, communication unit 3810 can be inwireless communication with a remote device 5360. That said, in somealternate embodiments, this communication can be wired. In an exemplaryembodiment, the remote device 5360 can be a laptop and/or a desktopcomputer that is also in signal communication with thereceiver/stimulator of the cochlear implant. In an embodiment where testunit 5360 outputs a current to electrode 5301, the receiver/stimulatorof the cochlear implant can detect this current via the electrodes(providing there is no open circuit—if there is, no detection willoccur, thus indicating the open circuit) of the electrode array, andcommunicate such to device 5360, whereby device 5360 can provide anindication that there is a reason not an open circuit. Indeed, it isnoted that in such an exemplary embodiment, the insertion guide 5300, insome embodiments, need not be in signal communication with remote device5360. In this regard, it is sufficient that test unit 5360 simplyprovide a controlled current to the electrode 5301. FIG. 54 providessuch an exemplary embodiment of an insertion guide 5400, where test unit5460 is a current generator apparatus, such as an apparatus thatincludes a battery with or without circuitry to provide a controlledoutput current to electrode 5301. In this embodiment, providing that thereceiver/stimulator of the cochlear implant is in telemetriccommunication via the inductance coil with a component that can indicatewhether or not the electrodes of the electrode array have received acurrent, a remote device in signal communication with thereceiver/stimulator can provide the indication to the surgeon of an opencircuit. That is, the guide 5400 simply provides the electrical signalfor testing of the open circuit.

That said, in an alternate embodiment where electrode 5301 receives orotherwise detects current/voltage (such as would be the case if there isno open circuit and the given electrodes of the electrode array areenergized at least as they pass electrode 5301), the test unit 5460 cananalyze the received signal (which can be a binary analysis that thesignal is present or is not present) and provide an indication to theuser that an open circuit exists and/or that no open circuit exists, orat least provide an indication to the user of the required voltage topush the current or some other indicia that will indicate the presenceof an open circuit. In an exemplary embodiment, an LED or the like canbe mounted on the guide at a location visible to the surgeon whileinserting the electrode array. The LED can be activated (it can be a redLED, for example) to indicate an open circuit. As will be understood,this embodiment can also be practiced without being in communicationwith another component, such as the computer 5360. Still, in somealternate embodiments, there can be utilitarian value with respect tocommunicating to another device that could have additional logiccircuitry so as to perform a more sophisticated analysis or so as toprovide a better indication or more informative indication.

Embodiments include an insertion guide by itself or an insertion guidethat is used in conjunction with other components that can provide anindication to the surgeon or other healthcare professional that an opencircuit is present. Any type of indication that can be provided to thesurgeon or healthcare professional that will indicate the presence of anopen circuit can be utilized in at least some exemplary embodiments.

It is briefly noted that while the embodiments depicted herein utilizeone electrode located at the top of the tube for open circuit testing,in other embodiments, a plurality of electrodes can be utilized. Stillfurther, while the embodiments depicted in the FIGs. depict a boxelectrode for open circuit testing, alternate embodiments can utilizeother types of electrodes, such as by way of example, ball electrodes.Indeed, in an exemplary embodiment, the electrode is a band electrodethat extends completely about the axis of the lumen 360°. Any number ofelectrodes at any spacing and any configuration that can enable opencircuit testing can be utilized in at least some exemplary embodiments.

It is briefly noted that in an exemplary embodiment, the electrode 5301utilized to test for open circuit can also be utilized as the insertionspeed and/or insertion depth measurement electrode detailed above andvis-a-versa. This is also the case in embodiments where a plurality ofelectrodes are utilized to test for an open circuit.

In view of the above, it can be seen that in an exemplary embodiment,there is an insertion guide for an electrode array that includes anactive functional component, wherein the active functional componentenables the measurement of the insertion speed and/or insertion depth ofthe electrode array. In an exemplary embodiment, the active functionalcomponent is an electrode of an open circuit monitor configured toestablish a capacitive coupling between the electrodes of the electrodearray in the electrode of the insertion guide. In an exemplaryembodiment, the active functional component of the electrode arrayinsertion guide enables at least one of array insertion speed monitoringor array insertion depth monitoring. Note that this is distinguishedfrom utilizing indicia on the insertion guide in a passive manner todetermine speed and/or insertion depth.

Note also that with respect to the embodiments where the guide includeslights and/or speakers and/or other data conveyance devices (e.g., avibrator that vibrates in the user's hand to provide indication of aphenomenon associated with the electrode array, etc.), the activefunctional component can be thus an indicator to a user of the insertionguide of a phenomenon associated with insertion of the array. Asdetailed above, such phenomena can include insertion speed and/orinsertion depth. As will be described in greater detail below, suchphenomena can also include array orientation, etc. in an exemplaryembodiment, any phenomenon associated with the insertion of theelectrode array can be used as a basis to provide an indicator to theuser of such phenomenon. It is noted that the electrode arrayorientation can include the orientation about the electrode axis, aswell as rotation about the other two axes. By way of example only andnot by way of limitation, orientation can be related to rotation aboutone or more of these axes.

In view of the above, it can be seen that the guide can have a firstfunctionality corresponding to an electrode array support, and a secondfunctionality corresponding to an electrode array open circuitprotection functionality for detecting an open circuit in the electrodearray.

FIG. 55 depicts an alternate embodiment of a portion of an electrodearray insertion guide. As can be seen, a fluidic passage 5510 is locatedin the wall 658 of the insertion guide tube 610. A plurality ofpassageways 5512 extend downward from the fluidic passage 55102 orifices5514 that open into the lumen 640. In an exemplary embodiment, thefluidic passage 5510 is utilized to conduct fluids from outside thecochlea into the lumen 640. In an exemplary embodiment, these fluids canbe drugs that have utilitarian value vis-à-vis insertion into thecochlea. In an exemplary embodiment, the electrode array insertion guideis configured to connect to a reservoir of such drug(s), which can beprovided to the fluidic passage 5510 under pressure, so as to be“injected” or otherwise transferred into the lumen 640. In an exemplaryembodiment, the drugs are injected or otherwise transferred into thelumen 640 as the electrode array is being inserted. In an exemplaryembodiment, this can coat at least a portion of the electrode array, andthe drugs are transferred into the cochlea as the electrode array movesinto the cochlea out of the insertion guide.

Note also that in an exemplary embodiment, a back pressure can beestablished in the lumen 640 so as to “push” the fluid injected orotherwise transferred into lumen 640 out of the end of the insertionsheath so that the drugs can be delivered to the cochlea irrespective ofwhether or not the drugs become coated onto the electrode array.

In an exemplary embodiment, the drugs perform a lubrication functionbetween the electrode array and the interior walls of the tube wall 658.In an exemplary embodiment, the drugs are anti-inflammatory drugs, andthese anti-inflammatory drugs exhibit lubrication properties that can beutilized to implement the embodiment of FIG. 55.

Thus, it is to be understood that in an exemplary embodiment, there is adevice, such as the guide of FIG. 55, that provides a functionality ofan electrode array guide, and drug delivery functionality in a mannerthat lubricates the insertion guide with respect to the array.

FIG. 56 depicts an alternate embodiment of an insertion guide havingdrug delivery functionality. As can be seen, fluidic passage 5510 alsohas passageways 5512 and outlet ports 5514 to the outside of theinsertion guide tube 610. In an exemplary embodiment, this can enablethe injection or otherwise transfer of the fluid in passageway 5510 intothe cochlea in directions normal to the longitudinal axis of theinsertion guide. It is noted that in alternate embodiments, the guideonly has orifices located on the outside of the tube wall 658. This isthe opposite of the embodiment depicted in FIG. 55, which has orificeslocated only on the inside of the tube wall 658.

In an exemplary embodiment, the insertion guide enables theadministration of drugs into the cochlea concurrently with insertion ofthe electrode array. By way of example only and not by way oflimitation, the drugs are injected or otherwise transferred into thecochlea at the same time that the electrode array is being inserted intothe cochlea. In an exemplary embodiment, the rate of drug deliveryrelative to the total amount of drugs delivered via the insertion guideor in total is at least about 1 to 1 with the length rate of insertionof the electrode array relative to the total length of the electrodearray. For example, if the total amount of drugs to be delivered is Aand the length of the electrode array is X, and the rate of insertion ofthe electrode array is 1/30^(th) the length of the electrode array everysecond, about 1/30^(th) of A will be delivered every second. That said,in an alternate embodiment, the guide can be utilized to administer afirst quantity of drug first, followed by insertion of the electrodearray, followed by the administration of a second quantity of drug.Still further, in an exemplary embodiment, the guide can be utilized toadminister a first quantity of drug first, and a second quantity of drugwhile the electrode array is being inserted into the cochlea, and then athird quantity of drug. Still further, in an exemplary embodiment, theguide can be utilized to administer a first quality of drug first, andthen a second quality of drug while the electrode array is beinginserted in the cochlea, where the second quantity and the firstquantity constitutes the total quantity of the drug administered, atleast with respect to the utilization of the insertion guide.

It is noted that while the above ratios are provided in exact terms, itis to be understood that there can be considerable tolerance withrespect to variations of a drug delivery regime relative to an electrodearray insertion regime. In this regard, it is noted that at least someembodiments of the insertion guide provide drug delivery functionalitythat enables drug delivery to be correlated with insertion depth of theelectrode array. This correlation can be relatively loose, and need notbe exact.

While the embodiments of FIGS. 55 and 56 concentrate on delivering thedrug along the axial length of the insertion guide, in an alternateembodiment, the drug is delivered at the tip of the insertion guide.FIG. 57 depicts an exemplary embodiment of an insertion guide 5700,where a drug delivery device 5701 is located at the tip. In an exemplaryembodiment, drug delivery device 5701 constitutes a fluidic passage 5812(with reference to FIG. 58, which depicts the tip of the guide) thatextends about the axis of the lumen (or anti-twist guide-channel 680, ifsuch is utilized). Orifices 5814 are in fluidic communication with thisfluidic passage 5812. The fluidic passage 5812 is in fluid communicationwith a fluidic passage 5810, corresponding to fluidic passage 5710 ofFIG. 57. In an exemplary embodiment, a fluid substance, such as a liquiddrug, is transported through fluidic passage 5812, and then injected orotherwise transferred out of orifices 5814. In an exemplary embodiment,this coats the electrode array with the drug about the entirecircumference thereof as the electrode array is pushed through the tipof the insertion guide into the cochlea, the electrode arraytransporting the drug into the cochlea as the electrode array istransferred into the cochlea. In an alternate embodiment, the orificesextend outward instead of inward. In an exemplary embodiment, theorifices extend both outward and inward.

FIG. 57 depicts an exemplary embodiment where a drug reservoir 5760 islocated in the handle. The drug reservoir 5760 is in fluid communicationwith fluid passage 5710 via fluidic conduit 57061. In an exemplaryembodiment, guide 5700 is configured to transport the drug contained inthe reservoir 5760 to the drug delivery device 5701 (or any other drugdelivery device—the embodiment of FIG. 57 is not mutually exclusive tothat configuration and/or the configuration of FIG. 58—again, anyfeature of any embodiment detailed herein can be combined with anyfeature of any other embodiment detailed herein unless otherwise noted).In an exemplary embodiment, the guide includes an actuation device thatenables the surgeon or the like to activate drug delivery. In anexemplary embodiment, a plunger device can be located in the handle thatpressurizes the drug in reservoir 5760 so as to reject the drug from theguide 5700. In an exemplary embodiment, the guide 5700 is configured tobe “charged” with the drug. In an exemplary embodiment, a connectionbetween reservoir 5760 and the outside of the guide is present, where asurgeon or other healthcare professional can insert the drug into thereservoir 5760. Indeed, in an exemplary embodiment, the reservoir 5760can include a self-sealing diaphragm or the like that enables a surgeonor other healthcare professional to insert a needle of a syringetherethrough, and inject the drug from the syringe into the reservoir5760 so as to “charge” the guide with the drug. (This is analogous tothe device that vaccines, etc., are stored in, where a healthcareprofessional inserts a needle into the diaphragm and withdraws the drugprior to giving an injection, except here, the drug is injected into thecontainer as opposed to withdrawn from the container.) This can haveutilitarian value with respect to managing the drugs. In this regard, inat least some exemplary embodiments, the drug need only be inserted intothe guide right before the use of that drug, thus avoiding a scenariowhere the drug becomes unstable due to age or temperature or the like.

That said, in an alternate embodiment, a fluidic connection to areservoir of the drug located remote from the guide 5700 can beutilized. Indeed, in an exemplary embodiment, a conduit can extend fromthe guide 5700 to a remote syringe, where a healthcare professionalother than the person handling the guide 5700 operates the drugdelivery. To this end, FIG. 59 depicts an exemplary embodiment of aninsertion guide 5900, that includes a flexible fluid conduit 59061extending from a connector 5955 to fluidic passage 5710. In an exemplaryembodiment, coupling 5955 is configured to be connected to a reservoirof a drug or the like, and the drug can be transferred through conduit59061 under pressure. In an exemplary embodiment, coupling 5955 can besnapped coupled or otherwise screwed onto the reservoir the drug. In anexemplary embodiment, connector coupling 5955 has a diaphragm or thelike that can be pierced by a syringe. In an exemplary embodiment, ahealthcare professional inserts the needle of the syringe through thediaphragm in connector 5955, and then injects the drug by depressing thehandle of the syringe, thus delivering the drug to the guide 5900, andultimately to the recipient. This structure of the connector 5955 can beanalogous to the structure of an IV tube where a healthcare professionalcan interact a drug into the IV without having to pierce the skin againbecause the skin is already pierced.

In view of the above, it is to be understood that in an exemplaryembodiment, there is an electrode array insertion guide comprising anassembly configured to provide direct array insertion functionality andancillary array insertion functionality to a user of the guide where theancillary functionality can be drug delivery functionality.

It is noted that while the embodiments depicted above focused on theorifices of the drug delivery system of the guide being located in theintracochlear portion of the guide, the orifices can be locatedelsewhere, such as in the portions of the guide that are not insertedinto the cochlea. The orifices of the drug delivery system can belocated anywhere within the guide that has utilitarian value. Also, itis noted that the teachings associated with the drug delivery systemsdetailed herein are not limited to an insertion guide that is insertedinto the cochlea. In this regard, FIG. 60 depicts an exemplary portionof an exemplary insertion guide that does not have a component that isconfigured to be inserted into the cochlea, where the orifices 5814 arearrayed on the inside of the tube at the location of the stop 204.

FIG. 61 depicts another alternate embodiment of an insertion guide 6100for a cochlear array. Here, an ultrasonic transducer 6104 is located onthe stop 204. Ultrasonic transducer 6 104 is connected to lead 6106,which is in signal communication with a device, not shown, that enablesreception and/or analysis of the signal received by transducer 6104. Inthis regard, guide 6100 includes an ultrasonic transducer positioned onthe extra cochlea section of the guide (with respect to the guide whenit is fully inserted into the cochlea) such that the working end of theultrasonic transducer directly abuts the round window and/or the ovalwindow and/or tissue around the cochlea promise and/or the tissue aroundthe round window and/or the oval window. The transducer 6104 can serveas an acoustic source for ultrasonic imaging. This can enable a surgeonor other healthcare professional to verify the array is positionedwithin the correct scala and check the final position of the array. Inan exemplary embodiment, the transducer 6104 enables the teachings ofU.S. patent application Ser. No. 13/965,348.

Consistent with the other embodiments detailed herein, while theembodiment of FIG. 61 is depicted as being utilized with a guide thathas an intracochlear portion, the teachings associated with thisembodiment can be utilized with insertion guides that do not have acomponent that is inserted into the cochlea.

In an exemplary embodiment, the guide 6100 includes a connection that isin signal communication with lead 6106. This connection can enable guide6100 to be connected to an ultrasonic imaging device that can utilizethe signals from the ultrasonic transducer 6104 to create an image. Inthis regard, it is noted that an exemplary embodiment includes the guide6100 connected to this ultrasonic imaging device. In this regard, FIG.62 depicts an ultrasonic imaging system, where a connector 6205 inelectrical communication with lead 6106 is connected to connector 6207which is an electrical communication with an ultrasonic imaging unit6250, such as that which can be obtained from the General ElectricCompany or the like. The ultrasonic imaging unit 6250 receives inputfrom the transducer 6104 and generates an image on an LCD screen and/ora cathode ray tube based on the input from transducer 6104.

Thus, in an exemplary embodiment, there is an insertion guide for anelectrode array, having an ancillary array functionality in the form ofan ultrasonic transmitter and/or receiver.

It is briefly noted that while the embodiment depicted in FIG. 62represents communication of the insertion guide with an ultrasonicimaging unit, FIG. 62 can be representative of other types of devices insignal communication or otherwise connected to the insertion array guide(e.g., an ECoG analysis program on a laptop or a desktop computer, anopen circuit test unit, etc.).

As noted above with respect to the embodiments utilizing the electrodein capacitive coupling with an electrode of the electrode array, theelectrodes of the insertion guide can be utilized to deduce certainfeatures associated with the electrode array. While the embodimentsdetailed above have been directed towards features associated with thestate of the electrical system of the electrode array, electrodes can beutilized to deduce a state in which the electrode array is currently inand/or a position of the electrode array. FIG. 63 depicts an exemplaryembodiment of an insertion guide 6300 that includes a plurality ofelectrodes that are located on the exterior of the insertion sheath. Ascan be seen, there is a tip electrode 6302, an electrode 6304 located onthe outer surface of the anti-twist section, and electrode 6305 locatedat the ramp portion between the anti-twist section in the proximalsection, and electrode 6306 located on the proximal section, and anotherelectrode 6307 located on the proximal section. These electrodes areutilized to monitor voltage and/or impedance characteristics between agiven electrode of the guide, and one or more electrodes of theelectrode array during insertion and/or after insertion into thecochlea. It is briefly noted that while the embodiment depicted in FIG.63 presents a plurality of electrodes on the insertion guide, it is tobe understood that some embodiments can be practiced utilizing only oneelectrode on the insertion guide. That said, in an alternate embodiment,additional electrodes can be utilized. Note further that while theelectrodes are depicted as being present on the top portion of theinsertion guide, in an alternate embodiment, the electrodes can belocated elsewhere such as on the bottom and/or on the lateral sides ofthe insertion guide. Indeed, a spread of electrodes can be located onthe top, the bottom, and the sides.

In an exemplary embodiment, the electrodes of the insertion guide areutilized to monitor the voltage and/or impedance profile between thegiven electrodes of the guide and the given electrodes of the electrodearray as the electrode array is inserted into the cochlea. In anexemplary embodiment, this can have utilitarian value with respect toproviding an indication as to the occurrence of a tip fold over. In anexemplary embodiment, one or more of the electrodes can serve thefunction as one or more of the electrodes of the teachings of U.S.patent application Ser. No. 14/843,255, filed on Sep. 2, 2015, namingBenjamin Johnston as an inventor. In an exemplary embodiment, theseelectrodes can have utilitarian value with respect to providing anindication as to the occurrence of buckling of the electrode array. Inan exemplary embodiment, one or more the electrodes conserve thefunctions as one or more of the electrodes of the teachings of U.S.patent application Ser. No. 14/843,259, filed on Sep. 2, 2015, namingFrank Risi as an inventor. In this regard, the electrodes of theinsertion guide can be utilized as part of a system that monitors theimpedance and/or voltage between the electrodes and the electrodes ofthe electrode array to determine angular insertion depth.

In an exemplary embodiment, the electrodes of the insertion guideprovide an absolute reference for monitoring the voltage and/orimpedance between the electrodes of the insertion guide and theelectrodes of the electrode array. In this regard, this can haveutilitarian value with respect to providing more accuracy than thatwhich results from utilizing the electrodes of the electrode array aloneas is done in the aforementioned patent applications described in theprior paragraph.

FIG. 65 depicts electrode 6307 in signal communication with a lead thatleads to connector 6320. In an exemplary embodiment, connector 6320 isconnected to a device that analyzes the output of lead.

FIG. 64 is a flowchart of a first method 300 for monitoring the physicalstate of the electrode array through the use of localized stimulation.The method 300 of FIG. 64 is sometimes referred to herein as a localizedmonitoring method as the method uses the delivery of localizedstimulation (i.e., current signals) to induce voltages at a plurality ofother contacts. For ease of illustration, method 6400 will be describedwith reference to the cochlear implant 100 of FIG. 1.

Method 300 begins at 302 where stimulation (i.e., one or more currentsignals) is delivered/sourced at a selected intra-cochlear electrode ofthe electrode array. In one specific example, the stimulation isdelivered at the most distal/apical electrode of the electrode array andis sunk at one or more of the electrodes of the electrode arrayinsertion guide 6300. The electrode that delivers the current signals,sometimes referred to herein as the “stimulating” or “source” contact(or source electrode) and the electrode that sinks the current signals,namely one or more of electrodes of the guide 6300, is sometimesreferred to herein as the “return” contact (or return electrode).Additionally, the two electrodes between which the stimulation isdelivered are collectively referred to herein as a “stimulating pair.”The remaining electrodes that are not part of the stimulating pair aredisconnected from the system ground (i.e., are electrically “floating”).

In general, two intra-cochlear contacts are selected for delivery of thestimulation. However, alternative embodiments may use an extra-cochlearcontact to source/sink current. Additionally, it is to be that the useof the most distal contacts for sourcing/sinking the current isillustrative and other contacts could be used in alternativeembodiments.

While the embodiment described above and herein utilizes the electrodesof the electrode array insertion guide 6300 as sinks, it is to beunderstood that in an exemplary embodiment, the electrodes of theelectrode array insertion guide can be utilized as sources. Thus, anydisclosure herein with respect to utilizing the electrodes of theelectrode array insertion guide as sinks corresponds to a disclosure ofutilizing the electrodes of the electrode array insertion guide assources.

While this embodiment details utilizing one single electrode of theelectrode array insertion guide as a sink (or source), it is to beunderstood that in alternate embodiments, the electrodes of theelectrode array can be utilized as sinks and/or sources sequentially. Inthis regard, in an exemplary embodiment, during a first temporal period,electrode 6307 can be utilized as a source, and then during a secondtemporal period, electrode 6306 can be utilized as a source, and thenduring a third temporal period, electrode 6305 can be utilized as asource, etc. In this regard, because the positions of the electrodes ofthe electrode array insertion guide are known, it can be possible totriangulate the position of the electrodes of the electrode array.

The electrode array is inserted into the recipient's scala tympani. Thescala tympani is substantially filled with a conductive fluid known asperilymph. As such, when current signals are delivered at one of theelectrodes of the electrode array insertion guide, at least a portion ofthe current will spread through the perilymph. For example, theconductive nature of the perilymph will cause at least some current toflow away from the contact. The flow of the current through theperilymph will cause the generation of voltages at the otherintra-cochlear stimulating contacts. That is, although the stimulus islocalized, due to the conductive perilymph the electric field spreadsand induces voltage at the other contacts.

At action 304, following the delivery of the current signals at theapical electrode of the electrode array, measurements are performed at aselected number of other intra-cochlear electrodes of the electrodearray utilizing the same electrode of the electrode array insertionguide or different electrodes of the electrode array insertion guide.That is, the voltage induced at the selected other electrodes as aresult of the delivery of the current signals at the apical electrode ismeasured. The electrodes at which the voltages are measured aresometimes referred to herein as “measurement” contacts. In theembodiment of FIG. 64, the measurement contacts may include any of theelectrodes of the electrode array insertion guide. Corollary to this,the measurement contacts can include any of the electrodes of theelectrode array.

In certain circumstances, the cochlear implant 100 associated with theelectrode array is configured to make a plurality of voltagemeasurements at substantially the same time in response to the deliveryof stimulation. In such embodiments, a single set of localized currentsignals is applied and the voltage induced at a selected number of themeasurement contacts is measured substantially simultaneously at themeasurement contacts. In other embodiments, the cochlear implant 100 isconfigured to measure the voltage at a single contact in response to thedelivery of a set of current signals. In such embodiments, a pluralityof sets of localized current signals are applied in sequence at the mostapical electrode of the electrode array and a voltage is measured at adifferent contact after each sequential stimulation. As such, in thecontext of FIG. 64, the delivery of single stimulation pattern may referto the delivery of one set of current signals (with subsequent,substantially simultaneous measurement at each of the selectedmeasurement contacts) or the sequential delivery of a plurality of setsof current signals (with subsequent measurement at one of the selectedmeasurement contacts after each set of current signals are delivered).

As noted above, stimulation delivered at an electrode will have aneffect on the other electrodes, and the effect may depend on a number offactors. However, a primary factor that controls the effects ofstimulation is the distance between the stimulating electrode and themeasurement electrode. For example, in the embodiment of FIG. 64, whenstimulation is delivered at the most apical electrode of the electrodearray, the voltage measured electrodes other than electrode 6307 shouldbe increasingly larger for electrodes along the insertion guide andshould increase the closer that the electrode is to the tip of theelectrode array insertion guide. Therefore, at 306 of FIG. 64, theinduced voltages measured at each of the measurement electrodes inresponse to the single stimulation pattern are evaluated relative to oneanother to determine the relative distance between the stimulatingelectrode of the electrode array and each of the measurement contacts(i.e., the contacts at which voltages are measured—where the electrodesof the electrode array insertion guide are utilized as the sinks, thecontacts at which the voltages are measured are those electrodes).Evaluation of the voltages relative to one another enables thedetermination of the physical state of the electrode array based on theevaluation of measurements relative to one another, the cochlear implant100 or a connected device may generate feedback to a surgeon or otheruser that provides information about the physical state of the electrodearray and/or the occurrence of an adverse event. In this regard, theinsertion guides detailed herein can be utilized in conjunction with theelectrode array to evaluate or otherwise determine the status of anelectrode array as detailed in the '255 patent application.

In view of the above, it is to be understood that in an exemplaryembodiment, one or more of the electrodes of the electrode arrayinsertion guide when utilized as a current sink “replace” one or more ofthe electrodes of the electrode array that are utilized as a currentsink when implementing the teachings of U.S. patent application Ser. No.14/843,255. In view of the above, it is to be understood that in anexemplary embodiment, one or more of the electrodes of the electrodearray insertion guide when utilized as a current source “replace” one ormore of the electrodes of the electrode array that are utilized as acurrent source when implementing the teachings of U.S. patentapplication Ser. No. 14/843,255.

In an exemplary embodiment, the electrode array insertion guide providessource currents from the electrodes thereof. In an exemplary embodiment,the electrode array insertion guide is configured with a currentgenerator that provides a specific current at a specific voltage fromthe electrode(s) of the guide. In this regard, the electrodes of theelectrode array insertion guide operate as a source with respect to theteachings of U.S. patent application Ser. No. 14/843,255. To this end,FIG. 65 depicts an exemplary insertion guide 6500, that provides acurrent and voltage generator 6520, which is in communication withelectrode 6307 via an electrical lead extending therefrom. In anexemplary embodiment, the generator 6520 can also be in communicationwith the other electrodes of the electrode array insertion guide. In anexemplary embodiment, the generator 6520 includes relays and/ortransistors and/or switching components that enable the generator toalternately switch delivery of current from one electrode to the otherelectrode. In this regard, in an exemplary embodiment, the generator6520 can have the functionality and/or the structure of the componentsof the receiver/stimulator of the cochlear implant of U.S. patentapplication Ser. No. 14/843,255 with respect to generating a sourcecurrent from the electrodes of the electrode array, when implementingthe teachings of that patent application. In an exemplary embodiment,the generator 6520 can be a battery that is connected to circuitry thatoutputs a stable current at a stable voltage. In an exemplaryembodiment, the generator 6520 can be adjustable so as to outputdifferent currents at different voltages. Consistent with the teachingsdetailed herein, the guide 6500 can have a switch or the like to allowthe surgeon to activate and/or deactivate the current generator 6520.Alternatively, and/or in addition to this, the guide 6500 can beconfigured so as to allow selective energizement and/or deenergizementof the electrodes of the guide. While some embodiments permit such aspart of the handheld guide, in some alternate embodiments, the guide isconfigured to be placed into communication with a control unit. Forexample, as seen in FIG. 66, guide 6500 can be equipped with a connector6320 in signal communication with the voltage/current generator 6520.The connector can be connected to a connector 6207 that is connected toa control unit 6650, which can be a personal computer or the like. In anexemplary embodiment, the control unit 6650 can control the output ofthe current generator 6520 with respect to the current, the voltage, andwhich electrodes are operated as the source. Note further that in someexemplary embodiments, the voltage/current generator 6520 is not part ofthe guide 6500, but instead is part of the control unit 6650. Indeed, insuch an exemplary embodiment, there can be separate leads from eachelectrode that extend to the connector 6320.

It is noted that in an exemplary embodiment, the control unit 6650 isthe implant itself. In an exemplary embodiment, it is thereceiver-stimulator unit of a cochlear implant, alone in someembodiments, or when placed into inductance communication with anexternal component or a component that replicates the functionality ofthe external component, etc. By way of example only and not by way oflimitation, a lead from the guide, such as the lead leading fromconnector 6207, could clip onto the existing extra cochlear electrode(sometimes referred to as the hardball) of the implant, allowing theimplant to look for open circuits, measure voltages, etc., through theelectrode on the guide. In this regard, in an exemplary embodiment, theelectrodes of the insertion guide can become an extension of the extracochlear electrode. Accordingly, an embodiment exists where anyfunctionality of the cochlear implant that relies on the extra cochlearelectrode can thus also rely on the electrodes of the insertion guide toachieve such functionality. Corollary to this is that in an exemplaryembodiment, any of the functions detailed herein that utilize theelectrodes of the insertion guide can be executed by the implants in atleast some exemplary embodiments when the implant is in signalcommunication with the implant, or at least when the insertion guide isconnected to the extra cochlear electrode of the electrode array.

Still, in at least some exemplary embodiments, the guide 6500 can beconfigured so that the surgeon or the like can toggle from one electrodeto another. For example, the guide can be provided with a switch or abutton that the surgeon depresses to selectively energize a givenelectrode. The electrodes can be energized in sequence by repeatedlypressing the button. In an exemplary embodiment, an indicator on theguide can be provided so as to convey information to the surgeon as towhich electrode is being operated as the source. By way of example onlyand not by way of limitation, an array of LEDs can be arrayed about theinsertion stop 204. As a given electrode is energized, the LEDs canlight. The LED at the 9 o′clock position could indicate that the closestelectrode to the stop has been energized (e.g., electrode 6307). The LEDat the 3 o′clock position (when viewing the stop 204 from the surgeonpoint of view) could indicate that the furthest electrode to the stophas been energized (e.g., electrode 6302). The electrodes in between cancorrespond to LEDs in between the 9 o′clock position in the 3 o′clockposition. Alternatively, LEDs having different colors can be utilized toindicate to the surgeon which electrode is being utilized as a source.

FIG. 67 depicts an alternate embodiment of the electrode array insertionguide, insertion guide 6700, that is utilized as a sink. Here, a leadextends from electrode 6307 to a connector 6320. Other leads also extendin a similar manner, but are not shown. In an exemplary embodiment,connector 6320 can be hooked up to or otherwise connected to a unit thatwill receive the signal from the electrodes when used as a sink, andanalyze that signal in a manner corresponding to how such would beanalyzed were that electrode to be part of the electrode array asutilized in U.S. patent application Ser. No. 14/843,255. By way ofexample only and not by way of limitation, in an exemplary embodiment, atest unit can be a personal computer in signal communication withconnector 6320. The personal computer can analyze the output fromconnector 6320 indicative of the current/voltage at electrode 6307 orany other electrode of the electrode array insertion guide, and analyzethe properties of the electrode array in the same manner as that whichis done in the '255 patent application. That said, in an exemplaryembodiment, the guide 6700 can be placed into signal communication withthe receiver/stimulator of the cochlear implant, and the cochlearimplant can be configured to utilize the electrodes of the insertionguide as the sink electrode when implementing the teachings of the '255application. Note also that this is the case with respect to embodimentswhere the electrodes of the electrode array insertion guide are utilizedas the source. That is, connector 6320 can allow the insertion guide tobe placed into signal communication with the receiver/stimulator of thecochlear implant, and the cochlear implant can be configured to utilizethe electrodes of the insertion guide as the source electrode whenimplement the teachings of the '255 application.

Note also that in an exemplary embodiment, whether the guide is utilizedas a source or a sink for the current, the insertion guide 6700 can beconfigured to be placed into signal communication with any ancillaryequipment utilized in the teachings of the '255 application so as toimplement the teachings thereof where the electrodes of the insertionguide are the source or the sink.

Any arrangement of the insertion guide that can enable electrodesthereof to operate as a source or a sink instead of utilizing theelectrodes of the electrode array as the respective source or a sinkwhen implementing the teachings of the '255 patent application can beutilized in at least some exemplary embodiments. Thus, in an exemplaryembodiment, the guide is configured to interface with any of thecomponents detailed in the '255 patent application to enable such.

The teachings detailed above have utilitarian value with respect todetermining or otherwise detecting electrode array tip fold over. Theteachings detailed above also have utilitarian value with respect todetermining angular insertion depth.

FIG. 68 depicts a flowchart of a first intra-operative method 1300 forsetting the angular insertion depth of the electrode array utilizing anelectrode of the electrode array insertion guide. FIG. 68 illustrates areal-time method that enables the determination of the current/present(i.e., actual) angular insertion depth of the electrode array within thecochlea.

Method 1300 begins at 1302 where the electrode array is at leastpartially inserted into cochlea. At 1304, during insertion of thestimulating assembly into the cochlea, the impedance between differentpairs of intra-cochlear contacts is measured, one contact being anelectrode of the electrode array and another contact being electrode ofthe electrode array insertion guide and used to determine the angularinsertion depth of the stimulating assembly.

In one embodiment, to measure the impedance between two intra-cochlearcontacts, bipolar electrical stimulation (i.e., one or more bipolarcurrent signals) is repeatedly delivered between a first intra-cochlearcontact (e.g., one of the electrodes the electrode array insertionguide) and a second intra-cochlear contact (e.g., one of the electrodesof the electrode array). After the delivery of each set of bipolarstimulation between the first and second intra-cochlear contacts, theimpedance between the first and second contacts is measured (e.g., atthe second intra-cochlear contact). As with the embodiment detailedabove with respect to FIG. 64, the contact that delivers the currentsignals is sometimes referred to herein as the “stimulating” or “source”contact and the contact that sinks the current is sometimes referred toherein as the “return” contact. Additionally, the two contacts betweenwhich the stimulation is delivered are sometimes collectively referredto herein as a “stimulating pair.” The remaining contacts that are notpart of the stimulating pair are disconnected from the system ground(i.e., are electrically “floating”).

It is to be appreciated that impedance measurements are made between twopoints, thus the impedance may be “measured” at either of the two points(i.e., it is a relative measurement between those two points). However,merely for ease of illustration of certain embodiments presented herein,the return contact of the stimulating pair is sometimes referred toherein as a “measurement” contact.

In general, the impedance between two intra-cochlear contacts in astimulating pair can be correlated to their physical proximity with oneanother and their location in the cochlea. Because one of the electrodesis mounted at a known location on the insertion guide, and the insertionguide is inserted into the cochlea by a known amount at a generallyknown angle, utilizing the electrodes of the electrode array insertionguide can have utilitarian value. The physically closer the contacts ofthe stimulating pair are to one another, the lower the impedance thatwill be measured between the contacts. At 1306, again while insertingthe electrode array, the impedance-to-proximity relationship is used toevaluate the plurality of impedance measurements relative to one anotherto determine the relative proximity between the two or moreintra-cochlear contacts and thus determine the real-time(current/present) angular insertion depth of the electrode array. Asdescribed further below, the method includes the selection of one ormore sets/pairs of intra-cochlear contacts for impedance measurementthat enables the angular insertion depth of the electrode array to bedetermined from the relative proximity of the one or more pairs ofintra-cochlear contacts.

In an exemplary embodiment, a given electrode of the electrode arraywill move relative to the electrode of the electrode array insertionguide as the electrode array is inserted in the cochlea. As it travelsthrough the cochlea and curves therein, a given electrode of theelectrode array will have a distance from the electrode of the electrodearray insertion guide that changes. The distance will grow larger andthen grow smaller as the electrode array snakes its way through thecochlea in a manner analogous to how distance between planets expandsand contracts. Because the distance is changed, the current and/orvoltage measured at a given sink contact will change. This can beutilized to determine the angular orientation according to the teachingsof U.S. patent application Ser. No. 14/843,259. Thus, in an exemplaryembodiment, whether the guide is utilized as a source or a sink for thecurrent, the insertion guide 6700 can be configured to be placed intosignal communication with any ancillary equipment utilized in theteachings of the '259 application so as to implement the teachingsthereof where the electrodes of the insertion guide are the source orthe sink.

Any arrangement of the insertion guide that can enable electrodesthereof to operate as a source or a sink instead of utilizing theelectrodes of the electrode array as the respective source or a sinkwhen implementing the teachings of the '259 patent application can beutilized in at least some exemplary embodiments. Thus, in an exemplaryembodiment, the guide is configured to interface with any of thecomponents detailed in the '259 patent application to enable such. To beclear, in an exemplary embodiment, electrode array insertion guide isconfigured to serve as a source and/or a sink contact in the teachingsof the 259 patent application.

To summarize, any of the features detailed above that enable aninsertion guide with electrodes to be utilized as source or sink toenable the teachings of U.S. patent application Ser. No. 14/843,255 canbe utilized to enable an insertion guide with electrodes to be utilizedas source or sink to enable the teachings of U.S. patent applicationSer. No. 14/843,259. Thus, the embodiments of FIGS. 63, 65, 66 (withpossible modifications to the unit 6650 for angular insertion), and 67can be utilized to implement the teachings of the '259 application aswell.

In view of the above, in an exemplary embodiment, there is an electrodearray insertion guide, wherein the guide includes an intracochlearportion configured to be inserted into the cochlea. In this exemplaryembodiment, the insertion guide has ancillary functionality of a voltageand/or impedance monitoring of the electrode array via an electrodemounted on the intracochlear portion thereof. It is to be understoodthat in an exemplary embodiment, the electrode array insertion guide hasa functionality of a reference for a measurement system. In view of theabove, in an exemplary embodiment, there is a cochlear electrode arrayinsertion guide, comprising an array guide, and an active functionalcomponent. In an exemplary embodiment, the active functional componentis an indicator to a user of the insertion guide of a phenomenonassociated with insertion of the electrode array. In an exemplaryembodiment, the phenomenon associated with insertion of the array is anarray orientation within the cochlea. In an exemplary embodiment, thereis an insertion guide having a functionality voltage and/or impedancemonitoring characteristics between two electrodes of the electrodearray.

In view of the above, it is to be understood that the insertion guidesdetailed herein provided utilitarian value with respect to methods. Inthis regard, FIG. 69 depicts an exemplary flowchart for a method 6900.Method 6900 includes method action 6910, which entails applying anacoustic source to a cochlea. In the exemplary embodiment, this isachieved via the use of the acoustic signal generator mounted on theguide as noted above. Method 6900 further includes method action 6920,which entails inserting an electrode array during the application of theacoustic source. Consistent with the teachings detailed above, theacoustic source could be a bone conduction actuator. In an exemplaryembodiment, the acoustic source is operated at a gain of less than about80 dBs.

FIG. 70 depicts another exemplary flowchart for an exemplary method,method 7000. Method 7000 includes method action 7010, which entailsexecuting method 6900. Method 7000 further includes method action 7020,which entails executing an ECoG measurement based on the acousticsource. In an exemplary embodiment, this is executed utilizing thedevices and systems detailed above. In view of the above, where theinsertion guide having the acoustic source signal generator is utilized,in an exemplary embodiment, the acoustic source bypasses the middle earto provide auditory stimuli for the ECoG measurements. Corollary tomethod 7000 is that the acoustic source evokes and auditory nerve actionpotential via bone conduction in at least some exemplary embodiments.

In at least some exemplary embodiments, the execution of the ECoGmeasurement can have utilitarian value with respect to determiningwhether or not electrode array is being properly inserted into thecochlea. Accordingly, in an exemplary embodiment, method 7000 canfurther include the action of temporarily halting the insertion of theelectrode array based on the ECoG measurement prior to full insertion ofthe electrode array. Indeed, in an exemplary embodiment, method 7000 canfurther include the action of withdrawing a portion of the electrodearray from the cochlea based on the ECoG measurement prior to the finalinsertion of the electrode array into the cochlea.

Still with reference to method 7000, in an exemplary embodiment, theaction of inserting the electrode array is executed during a firsttemporal period and a second temporal period, wherein during the firsttemporal period, the electrode array is inserted into the cochlea alonga first trajectory relative to the very beginning of the cochlea andduring the second temporal period, the electrode array is inserted intothe cochlea along a second trajectory relative to the very beginning ofthe cochlea. In this regard, by way of example only and not by way oflimitation, the first trajectory can be established by the insertionguide when held at a first angle relative to the outside of the cochlea,or more specifically, relative to the tangent surface at thecochleostomy. In an exemplary embodiment, this angle could be 10°.Because of the nature of the insertion guide, the electrode array wouldbe inserted into the cochlea along a first trajectory controlled by thisangle. The second trajectory can also be that established by theinsertion guide when held at a second angle relative to the outside ofthe cochlea, or more specifically, relative to the tangent surface ofthe cochleostomy. In an exemplary embodiment, this angle can be 15°.Again, because of the nature of the insertion guide, the electrode arraywould be inserted into the cochlea along a second trajectory controlledby this angle. It is to be understood that the method 7000 furthercomprises at least one of during the first temporal period or subsequentto the first temporal period, evaluating the ECoG measurementdetermining that the second trajectory should be adopted for insertionbased on the ECoG measurement. In this regard, in an exemplaryembodiment, the ECoG measurement could indicate that the electrode arrayis piercing a wall of the cochlea that it should not be piercing. Thus,there is utilitarian value with respect to changing the angle oforientation of insertion of electrode array into the cochlea. Stillfurther, in an exemplary embodiment, the ECoG measurement could indicatethat the electrode array is inserted into the wrong portion of thecochlea. Any data that is conveyed by the ECoG measurement that can haveutilitarian value indicating that a different trajectory of electrodearray insertion should be utilized, can be used in at least someexemplary embodiments as a basis for which to determine that thetrajectory of insertion should be adjusted or otherwise changed.

Still referring back to method 6900, in an exemplary embodiment, theacoustic source is an ultrasonic imaging signal consistent with theutilization of an ultrasonic transducer mounted on the guide as detailedabove.

It is noted that in an exemplary embodiment, the insertion guide ingeneral, and the insertion sheath in particular, can be partially formedfrom or otherwise include layers of thin film circuits with the activecomponents (electrodes, circuits for transducers, MEMS electronics,etc.) needed to produce the added functionality. By way of example onlyand not by way of limitation, the tube through which the electrode arrayis inserted could be formed by taking a thin film and laying such flat.Electrical components can be located on the film according to a specificpattern. The film can then be rolled around the mandrel or the like sothat the layer stack upon themselves as the film is rolled about thelayer. The electronics will thus be located between and/or in the layersand position in the resulting tube accordingly, this tube could beutilized as part of the insertion guide in general, and the lumenthrough which the electrode array travels during insertion thereof inparticular.

For purposes of concept illustration, FIG. 71 depicts an exemplarythin-film 7120 having located thereon circuit traces. A first circuittrace includes a lead 7130 and an electrode 7132. A second circuit traceincludes a lead 7140 and an electrode 7142. The circuit traces arelocated on the film 7120 such that, when rolled, the first circuit traceis located closer to the inside of the resulting lumen and the secondcircuit trace is located close to the outside of the lumen. This is seenin FIG. 72, which depicts a view of the insertion tube showing thepositions of the respective circuit traces, and the layers establishedby the rolling of the film. To be clear, the layers of the film form thetube wall 658 and thus the electrical circuits are embedded in the wallowing to the rolling.

It is noted that the electrode array orientation can include theorientation about/relative to the electrode axis, as well as rotationabout the other two axes. By way of example only and not by way oflimitation, orientation can be related to rotation about one or more ofthese axes. Any orientation of the electrode array that can be evaluatedor otherwise estimated utilizing the teachings detailed herein and/orvariations thereof as a basis in whole or in part to control theelectrode array insertion process can be utilized at least someexemplary embodiment in exemplary methods and/or in exemplaryapparatuses. It is also noted that in some alternate embodiments, thedirection of approach of the electrode array can also be utilized tocontrol the insertion process. In this regard, in an exemplaryembodiment, the teachings detailed herein can be utilized to evaluate orotherwise estimate a direction of approach of the electrode array, andthe insertion process can be controlled or otherwise adjusted based onthe direction of approach.

As noted above, the insertion guide can incorporate visual indicators toprovide intraoperative feedback to the surgeon. As detailed above,exemplary embodiments have LEDs or the like arrayed about the stop.Still further, in an exemplary embodiment, a liquid crystal display orthe like can be incorporated in or on the insertion guide. In thisregard, FIG. 73 depicts an exemplary embodiment of an insertion guide7300 which includes LCD 7410 mounted on the insertion guide tube. LCD7410 is in electrical communication with other components of the guideand/or other systems remote from the guide via electrical lead 7406. Inan exemplary embodiment, the LCD can provide text and/or numerical datato the surgeon during implantation/insertion of the electrode array. TheLCD or the other visual indicators can be located anywhere on the guidethat will be within the surgeon's immediate field-of-view, but alsowhere the indicator will not obstruct the surgeon's field-of-view of thepertinent portions of the anatomy of the recipient and/or the pertinentportions of the guide 7300 during insertion of the electrode array. Inan exemplary embodiment, the indicators provide information pertainingto insertion depth, which can include the absolute depth and/or anindication that the electrode array has reached the intended orprogrammed stopped depth. Indication can be an insertion speed, whichcan be absolute speed of insertion or can be an indication that theinsertion speed limit has been exceeded. The indication can be anadverse measurement indication. This measurement can be a generalindication, such as an indicator that something has gone wrong whateverthat is, or specific indication, such as an indication explicitlyrelating to tip fold-over, basilar membrane contact, scala dislocation,etc.

As noted above, embodiments include an insertion guide configured tocommunicate with a receiver/stimulator of a cochlear implant. In thisregard, FIG. 74 depicts an exemplary insertion guide 7400 which ispresented by way of concept. Insertion guide 7400 is a functionalcomponent FC mounted thereon. This functional component isrepresentative of any of the additional functionalities of the insertionguide detailed herein and/or variations thereof. For example, element FCcould be an electrode, it could be the acoustic stimulation generator,or it could be the ultrasonic transducer. FC could also be any of theindicators detailed herein (e.g., the LCD screen). As can be seen,insertion guide 7400 includes connector 64705 in electricalcommunication with the functional component FC via electrical lead 746.Connector 64705 is connected to connector 7407 of inductance coil 7444.In an exemplary embodiment, inductance coil 7444 includes coil 7410configured to establish a magnetic inductance field so as to communicatewith the corresponding coil of the receiver-stimulator of the cochlearimplant. Inductance coil 7444 includes a magnet 7474 so as to hold theinductance coil 7474 against the coil of the receiver/stimulator of thecochlear implant in a manner analogous to how the external component ofthe cochlear implant is held against the implanted component, and howthe coils of those respective components are aligned with one another.While the embodiment depicted in FIG. 74 depicts no other functionalcomponent between the functional component FC and the inductance coil7444, in an alternate embodiment, one or more of the units detailedherein can be located there between. By way of example, generator 6520with respect to the insertion guide 6500 detailed above can be locatedtherebetween or otherwise be in signal communication with the leads soas to establish communication with that element with the cochlearimplant. In an exemplary embodiment, a communications unit or the likeis located between or otherwise is in signal communication with theleads so as to establish communication with the cochlear implantreceiver-stimulator. In an exemplary embodiment, the insertion guideincludes logic or a processor or other type of control unit that enablesthe insertion guide to work in conjunction with the cochlear implant soas to execute any of the methods detailed herein, including the methodsassociated with the '255 and the '259 applications where one or moreelectrodes of the electrode array insertion guide are utilized in astate of one or more electrodes of the electrode array as taught inthose applications.

It is noted that at least some exemplary embodiments include utilizationof the insertion guides detailed herein and/or variations thereof with arobotic electrode array insertion system. In this regard, FIG. 75 is aperspective view of an exemplary embodiment of an insertion system 400.It is noted that the embodiment depicted in FIG. 75 is presented forconceptual purposes only. Features are provided typically in thesingular show as to demonstrate the concept associated therewith.However, it is noted that in some exemplary embodiments, some of thesefeatures are duplicated, triplicated, quadplicated, etc. so as to enablethe teachings detailed herein and/or variations thereof. Briefly, it isnoted that any teaching detailed herein can be combined with a roboticapparatus and/or a robotic system according to the teachings detailedherein and/or variations thereof. In this regard, any method actiondetailed herein corresponds to a disclosure of a method action executedby a robotic apparatus and/or utilizing a robot to execute that actionand/or executing that method action is part of a method where otheractions are executed by robot and/or a robotic system etc. Stillfurther, it is noted that any apparatus detailed herein can be utilizedin conjunction with a robotic apparatus and/or a robot and/or a systemutilizing such. Accordingly, any disclosure herein of an apparatuscorresponds to a disclosure of an apparatus that is part of a roboticapparatus and or a robotic system etc. and or a system that includes arobotic apparatus etc.

System 400 includes a robotic insertion apparatus including arm 7510 towhich insertion guide 200 or any other insertion guide according to theteachings detailed herein and/or variations thereof is attached (e.g.,bolted to arm 7510). In this exemplary embodiment, arm 7510 is depictedas a single structure extending from the insertion guide to mount 7512.However, in an alternate embodiment, arm 7510 can be a multifacetedcomponent which is configured to articulate at various locationsthereabout.

In an exemplary embodiment, arm 7510 is releasably connected by way of areleasable connection to mount 7512, which is supported by a support andmovement system 420, comprising support arm 422 which is connected tojoint 426 which in turn is connected to support arm 424. Support arm 424is rigidly mounted to a wall, a floor, or some other relativelystationary surface. That said, in an alternative embodiment, support arm424 is mounted to a frame that is attached to the head of the recipientor otherwise connected to the head of the recipient such that globalmovement of the head will result in no relative movement of the system400 in general, and the insertion guide in particular, relative to thecochlea. Joint 426 permits arm 2510, and thus the insertion guide, to bemoved in one, two, three, four, five, or six degrees of freedom. (It isnoted again that FIG. 75 is but a conceptual FIG.—there can be jointslocated along the length of arm 7510, so as to enable arm 75102articulate in the one or more the aforementioned degrees of freedom atthose locations. In an exemplary embodiment, joint 426 includesactuators that move mount 7512, and thus the insertion guide, in anautomated manner, as will be described below. In an exemplaryembodiment, the system is configured to be remotely controlled viacommunication with a remote control unit via communication lines ofcable 430. In an exemplary embodiment, the system is configured to beautomatically controlled via a control unit that is part of the system400. Additional details of this will be described below.

The system 400 further includes by way of example only and not by way oflimitation, sensor/sensing unit 432. That said, in some embodiments,sensor 432 is not part of system 400. In some embodiments, it is aseparate system. Still further, in some embodiments, it is not utilizedat all with system 400. While sensor 432 is depicted as being co-locatedsimultaneously with the insertion guide, etc., as detailed below, sensor432 may be used relatively much prior to use of the insertion guide.Sensing unit 432 is configured to scan the head of a recipient andobtain data indicative of spatial locations of internal organs (e.g.,mastoid bone 221, middle ear cavity 423 and/or ossicles 106, etc.) In anexemplary embodiment, sensing unit 432 is a unit that is also configuredto obtain data indicative of spatial locations of at least somecomponents of the insertion guide and/or other components of the roboticapparatus attached thereto. The obtained data may be communicated toremote control unit 440 via communication lines of cable 434. As may beseen, sensor 432 is mounted to a support and movement system 420 thatmay be similar to or the same as that used by the robotic apparatussupporting the insertion guide.

In an exemplary embodiment, sensing unit 432 is an MRI system, an X-Raysystem, an ultrasound system, a CAT scan system, or any other systemwhich will permit the data indicative of the spatial locations to bedetermined as detailed herein and/or variations thereof. As will bedescribed below, this data may be obtained prior to surgery and/orduring surgery. It is noted that in some embodiments, at least someportions of the insertion guide are configured to be better imaged orotherwise detected by sensing unit 432. In an exemplary embodiment, thetip of the insertion guide includes radio-opaque contrast material. Thestop of the insertion guide can also include such radio-opaque contrastmaterial. In an exemplary embodiment, at least some portions ofinsertion guide in general, and the robotic system in particular, or atleast the arm 7510, mount 7512, arm 422, etc., are made ofnon-ferromagnetic material or other materials that are more compatiblewith an MRI system or another sensing unit utilized with the embodimentof FIG. 75 than ferromagnetic material or the like. As will be describedin greater detail below, the data obtained by sensing unit 432 is usedto construct a 3D or 4D model of the recipient's head and/or specificorgans of the recipient's head (e.g., temporal bone) and/or portions ofthe robotic apparatus of which the insertion guide is a part.

It is also noted that in some exemplary embodiments of system 400, thereare actuators or the like that drive the electrode array through theinsertion guide into the cochlea. These actuators can be in signalcommunication with the control unit. In an exemplary embodiment, thecontrol unit can control the actuators to push the electrode array intoand/or out of the cochlea as will be described in greater detail below.Concomitant with the robotic assembly supporting the insertion guide, inan exemplary embodiment, the control unit is configured to automaticallycontrol these actuators.

FIG. 76 is a simplified block diagram of an exemplary embodiment of aremote control unit 440 for controlling the robotic apparatus supportingthe insertion guide and sensing unit 432 via communication lines 430 and434, respectively. Again, it is noted that in some alternateembodiments, the remote control unit 440 is an entirely automated unit.That said, in some alternate embodiments, the remote control unit can beoperated automatically as well as manually, which details will bedescribed below.

Remote control unit 440 includes a display 442 that displays a virtualimage of the mastoid bone obtained from sensor 432 and may superimpose avirtual image of the insertion apparatus onto the virtual imageindicative of a current position of the drill bit relative to the earanatomy. An operator (e.g., surgeon, certified healthcare provider, etc)utilizes remote control unit 440 to control some or all aspects of therobotic apparatus and/or sensing unit 432. Exemplary control may includedepth of insertion guide insertion, angle of guide insertion, speed ofadvancement and/or retraction of electrode array, etc. Such control maybe exercised via joystick 450 mounted on extension 452 which fixedlymounts joystick 450 to a control unit housing. Such control may befurther exercised via joystick 460 which is not rigidly connected tohousing of remote control unit 440. Instead, it is freely movablerelative thereto and is in communication with the remote control unitvia communication lines of cable 462. Joystick 462 may be part of avirtual system in which the remote control unit 440 extrapolates controlcommands based on how the joystick 462 is moved in space, or joystickmay be a device that permits the operator more limited control over thecavity borer 410. Such control may include, for example an emergencystop upon release of trigger 464 and/or directing the robot to drive theinsertion guide further into the cochlea by squeezing the trigger 464(which, in some embodiments, may control a speed at which the insertionguide is advanced by squeezing harder and/or more on the trigger). Inthe same vein, trigger 454 of joystick 450 may have similar and/or thesame functionality.

Control of the robot assembly supporting the insertion guide may also beexercised via knobs 440 which may be used to adjust an angle of theinsertion guide in the X, Y and Z axis, respectively. Other controlscomponents may be included in remote control 440.

FIG. 77 depicts an exemplary insertion guide which can correspond to anyof the insertion guide detailed herein and/or variations thereof, or anyother insertion guide for that matter, further including an electrodearray insertion actuator 7720. In an exemplary embodiment, actuatorassembly 7720 includes a passageway therethrough through which theelectrode array extends. The actuator assembly drives the electrodearray in a manner replicating that by which the surgeon pushes theelectrode array forward along the insertion guide and into the insertiontube and thus into the cochlea.

FIG. 78 depicts an exemplary embodiment of the actuator assembly 7720.As can be seen, actuator assembly includes two actuators 7824 in theform of wheels mounted to electric motors that rotate the wheels in acounterclockwise direction so as to advance the electrode array, and ina clockwise direction so as to retract the electrode array. Actuatorassembly 7720 further includes a floor 7822. The floor 7822 works incombination with the actuators 7824 so as to “trap” the electrode arraythere between with a sufficiently compressive force so that the frictionforces between the actuators 7824 and the electrode array enable theactuators 7824 to drive the electrode array forward and/or backwards,but not enough so as to damage the electrode array.

FIG. 78 functionally depicts an electrode array 145 “loaded” in actuatorassembly 7720 prior to driving the electrode array into the insertionsheath. FIG. 79 functionally depicts the electrode array being drivenforward (FIG. 79 is depicted in a functional manner—in reality, theelectrode array 145 would extend up the ramp and then into the insertionsheath), and FIG. 80 functionally depicts the electrode array beingretracted from the position seen in FIG. 79.

While the embodiment of the actuator assembly depicted in FIG. 77includes two top actuators, in an alternate embodiment, only one topactuator is utilized and/or in another embodiment, three or four or fiveor six or more actuators are utilized. Also, in an exemplary embodiment,one or more bottom actuators can also be utilized. Note also thatinstead of the actuators being located on the top and the floor 7822being on the bottom, the actuators can be located on the bottom and thefloor can be located on the top.

It is noted that while the embodiment of FIG. 77 is depicted utilizingactuators having round wheels, in an alternate embodiment, other typesof working and of the actuators can be utilized. In this regard, FIG.81A depicts an exemplary actuator assembly 8120, that includesCaterpillar drives 8124 that operate on a conveyor belt principle, whichCaterpillar drives squeeze the electrode array there between ever soslightly to obtain the sufficient friction so as to drive the electrodearray forward and/or backwards. Also, while the embodiments depictedherein present the actuators being located one on top of the other, inan alternate embodiment, the actuators can be located side by side.Indeed, while the views depicted in the FIGs. have been presented forpurposes of depicting a side view of the actuator (that corresponding toFIG. 76), in alternate embodiment, these views can be considered top useand/or bottom views etc.

Note also that the actuators can be located on the top and the sides andthe bottom.

In an alternate embodiment, the actuator can be a linear actuator thatdrives the electrode array forward and/or backward by extending theworking end of the actuator and retracting the working end of theactuator, where the working end is coupled in some form or another toelectrode array. In this regard, FIG. 81B depicts an exemplary actuatorapparatus 8123 that includes a retractable and extendable boom 8131. Theactuator of the actuator apparatus 8123 is a linear actuator. That said,in an alternate embodiment, a rotary actuator can be utilized to extendand/or retract the boom 8131 (e.g., via the use of gears and sprocketsor a rack and pinion system, or by the use of frictional rollers thatextend and retract the boom 8131 as a result of friction forces betweenthe rollers and the service of the boom 8131). Any actuator that canlinearly extend and/or retract the boom 8131 can utilize in at leastsome exemplary embodiments. Still with reference to FIG. 81B, at the endof the boom, there are grips 8133. In an exemplary embodiment, grips8133 are semicircular components sized and dimensioned to interface witha portion of the electrode array that is gripped. FIG. 81B depicts thegrips on one side of the boom 8131. Not depicted in the figure are thegrips on the other side of the boom which work in conjunction with thegrips scene in the figure. In an exemplary embodiment, grips 8133 can beconfigured to open and close about the electrode array so as toreleasably grip the electrode array. In an exemplary embodiment, thesystem of which the actuator assembly 8123 is a part is configured toautomatically open and close the grips 8133/grip and release theelectrode array via controlled actuation of actuators or othermechanical components and/or other electromechanical components thatmove the grips 8133 to open and/or close about the electrode array. FIG.81B depicts the boom 8131 in a retracted state, such as that whichexists when the electrode array is first loaded onto the actuatorassembly 8123 prior to insertion into the cochlea. FIG. 81C depicts theboom 8131 in an extended state, such as that which occurs when theelectrode array has been inserted into the cochlea via the actuatorassembly.

FIG. 81D depicts an alternate embodiment of a grip 8143, where an equaland opposite grip is located on the far side, and is eclipsed by thegrip on the near side in the view of FIG. 81D. In an exemplaryembodiment, the grip 8143 functions more as a tweezers or the like andgrips the so-called “handle portion” of the extra cochlear portion ofthe electrode array—an area that is wider than the other portions of theelectrode array and also flatter so as to enhance gripping by a tweezerlike device during insertion. In at least some exemplary embodiments,the “handle portion” is an elongated shallow triangular shape with twolegs that extend a length many times that of the third leg, where thethird leg is normal to the direction of extension of the electrodearray. In this regard, the elongated feature of the grip 8143 seen inFIG. 81D is such that the grips grip the shallow triangular portion ofthe electrode array so as to support and otherwise insert the electrodearray into the cochlea. As with the embodiment detailed above, the grips8143 are attached to electro mechanical actuators that open and closethe grips about the electrode array to releasably grip the electrodearray for insertion into the cochlea or otherwise to support theelectrode array.

FIG. 81E depicts a view of the boom 8131 and the grips 8143 looking downthe axis of the boom 8131 with the grips 8143 in a closed state (e.g.,that which would be the case when the grips are gripping electrodearray). FIG. 81F depicts a view having an orientation corresponding tothat of FIG. 81E, but with the grips 8143 in an open position.

FIG. 81G depicts yet another alternate exemplary embodiment of anexemplary actuator assembly, where the grip 8153 extends and anelongated fashion. As with the embodiments detailed above, the grips8153 open and close via electromechanical actuators. Here, the grips8153 are elongated such that the grips extend a considerable way beyondthe end of the boom 8131. This can provide additional clearance wheninserting the electrode array into the cochlea. In this regard, thegrips 8153 are configured so as to be structurally rigid so as to beable to support and grip and insert the electrode array even when theelectrode array is held at the tips of the grips 8153 (e.g,. the distaltips, as is depicted by way of example in FIG. 81H).

Any arrangement of advancing and/or retracting the actuator assembly canbe utilized in at least some exemplary embodiments.

To be clear, the embodiment of FIG. 75 depicted above can also includethe actuator assembly's detailed herein and/or variations thereof. Thatis, insertion guide 7700 can be attached to the arm 7510 of the system400. Moreover, the actuators of the actuator assembly can be placed intosignal communication with the control unit 440 or any other control unitof the system 400 to enable the control unit to advance and/or retractthe electrode array. Note also that in some alternate embodiments, thesystem 400 is such that the only non-manually actuating component is theactuator assembly. That is, in an exemplary embodiment, system 400 canbe such that the frame of the like is placed around the recipient's headand secured thereto, and the arm 7510 supporting the insertion guideattached thereto can be moved manually by the surgeon, such that thesurgeon can align or otherwise place the insertion guide into thecochlea. In this regard, by way of example only and not by way oflimitation, the insertion guide can be configured so as to attached tothe arm 7510 on a trolley or the like. In an exemplary embodiment, thesurgeon moves arm 7510 into position so that the insertion guide isaligned with the cochlea, at the desired angle, etc., and then besurgeon manually pushes the insertion guide forward into the cochlea (inthe case of an intra-cochlear insertion guide) or against the cochlea inthe case of a non-intra-cochlea insertion guide). After that, theactuator assembly can be utilized in a remote-controlled and/orautomated manner.

That said, in an alternate embodiment, the general positions of thesystem 400 can be established utilizing manual methods, and then thepositions can be refined utilizing automated/remote controlled methods(e.g., the actuators on the arm 7510 and/or the actuator at joint 426can be actuated so as to finally position the insertion guide.

Note also that in some exemplary embodiments, the actuator assembly'sdetailed herein and/or variations thereof that are utilized to advanceand/or retract the electrode array are configured to be utilized with aninsertion tool that is handheld instead of being attached to arm 750system 400. To this end, FIG. 82 depicts an exemplary insertion tool8200 that includes actuator apparatus 7720 as seen. Hereinafter, thereference will often be made to actuator apparatus 7720 as utilized inconjunction with other components detailed herein. Any disclosure hereinof the utilization of actuator apparatus 7720 in conjunction with otherteachings detailed herein corresponds to a disclosure of the utilizationof the actuator apparatus 8123 or any of the other actuator apparatusesdetailed herein or variations thereof utilized to grip and supportand/or insert the electrode array into the cochlea. FIG. 82 depicts aconnector 67405 in signal communication with an actuator apparatus 7720,which connector is connected to connector 7407, which in turn isconnected to a lead which extends to the control unit. In an exemplaryembodiment, the surgeon holds the tool 8200 in the traditional manner ofuse, but the control unit controls the actuation of the actuator 7720 toadvance and/or retract the electrode array. In an exemplary embodiment,the surgeon or other healthcare professional can exercise overridecontrol over the insertion of the electrode array and/or the retractionof the electrode array. For example, switching components of the like orother types of input devices can be located on the tool 8200 so that thesurgeon or the like can provide input into the system of which the tool8200 is a part. In an alternate embodiment, the tool 8200 can include aninput device that interacts with the surgeon, where the surgeon providesthe direction to the system advance and/or retract the electrode array,but the control unit evaluates the inputs from the surgeon and controlsthe actuation accordingly. By way of example only and not by way oflimitation, such a system can be analogous to a fly by wire system on anaircraft, where the pilot moves the controls in a manner correlated tothe direction that the pilot wants the aircraft to move, and the flightcontrol system controls everything else to achieve the desired outcome.Note also that any the other actuators detailed herein and/or variationsthereof can be part of a system that is operated in a similar manner. Byway of example only and not by way of limitation, the system 400 can beconfigured such that the surgeon pushes on the arm 7510 to move theinsertion guide is desired, but the system 400 moves the arm 7510 usingactuators. That is, the system 400 is configured to sense or otherwisedetect the force is applied on to the structure thereof by the surgeon,and then determine what actuator action should be executed so as toposition the insertion guide at the desired location in a manneranalogous to fly by wire.

It is noted that the electrical lead assembly and the connectors thereofdepicted in FIG. 82 can be applicable to any of the insertion guidesdetailed herein and/or variations thereof so as to place the insertionguide in general, and the actuator assembly thereof in particular, intosignal communication with the control unit or other controllers of thesystem. Note also that in an exemplary embodiment, the lead apparatusdepicted in FIG. 82 can be utilized to also convey the other signalsdetailed herein and/or variations thereof with respect to the otherfunctionalities associated with the insertion guides. Alternatively,and/or in addition to this, the other lead apparatuses detailed hereinand variations thereof can be utilized to convey the signals from theactuator apparatus 7720 to the control unit or the like when theinsertion guides detailed above are utilized in conjunction with theactuator assembly so as to provide a machine drive to advance and/orretract the electrode array. Any device, system and/or method ofcommunication between any functional component of any of the insertionguides detailed herein and/or variations thereof with a control unitand/or vice versa and/or the implantable component of the electrodearray, etc., can be utilized in at least some exemplary embodiments

It is also noted that while the embodiments detailed herein have beendirected towards an electrode array guide, it is also noted that in somealternate embodiments, an electrode array support is instead utilized,which support may not necessarily guide the electrode array, butotherwise might simply support the electrode array proximate to thecochlea. Note that in an electrode array support can also be anelectrode array guide, and vice versa.

In view of the above, it can be understood that in an exemplaryembodiment, there is an apparatus, such as any of the insertion guidesdetailed herein and/or variations thereof, that includes an electrodearray support, and an actuator. In at least some of these exemplaryembodiments, the apparatus is configured to inserts an electrode arrayinto cochlea by a controlled actuation of the actuator. In an exemplaryembodiment of such an exemplary embodiment, the controlled actuation isat least partially based on electrical phenomenon of the recipient. Someadditional details of such will now be described.

As noted above, some exemplary embodiments of the insertion guides canbe utilized with or otherwise as a part of an ECoG system. By way ofexample only and not by way of limitation, the embodiments of FIGS. 19to 40 can be utilized in part or in whole in conjunction with an ECoGsystem. Accordingly by way of example only and not by way of limitation,in an exemplary embodiment, those embodiments can be combined with theactuator apparatus of the embodiment of FIG. 76 or the variationsthereof. That said, in an alternate embodiment, the embodiment of FIG.76 and variations thereof can be utilized in conjunction with a separateECoG system completely separate from the insertion guide, except that acontrol unit or the like receive signals or other data from the separateECoG system and evaluates the systems to output a signal to the actuatorapparatus of the insertion guide, thus controlling the actuatorapparatus to advance and/or retract the electrode array.

FIG. 83 depicts an exemplary functional schematic of an exemplary systemthat includes the ECoG test unit 3960 detailed above in signalcommunication with a control unit 8310 which is in turn in signalcommunication with the actuator assembly 7720.

(Briefly, it is noted that while the following embodiment is describedin terms of an ECoG test unit that is integral with the system 400 ingeneral, and utilizes componentry that is a part of the robot assembly(e.g., an ECoG measurement electrode supported by a insertion guide,concomitant with the embodiments detailed above the insertion guides),alternative embodiments utilize an ECoG system that is separate from thesystem 400 in general, and separate from the robot assembly inparticular. By way of example only and not by way of limitation, themeasurement electrodes of the ECoG system could be mounted in atraditional manner, and, in fact, could be held by hand, and theacoustic signal generator could also be held by hand, and the ECoGsystem could provide a signal to the system 400 in general, and thecontrol unit thereof in particular, which control unit evaluates thesignal so as to implement the teachings detailed herein.)

Also functionally depicted in FIG. 83 is the optional embodiment wherean input device 8320 is included in the system (e.g., which could be onan embodiment where the actuator assembly 7720 is part of a hand tool(e.g., the embodiment of FIG. 82) or where actuator assembly 7720 ispart of an insertion guide, where the input device 8320 is locatedremote from the insertion guide, which could be part of a remote unit440). In an exemplary embodiment, the input device 8320 could be thetrigger for 54 and/or 464 of the remote control unit 440. In anexemplary embodiment, the input device 8320 could be a trigger on thetool 8200. Again, in an exemplary embodiment, the input device 8320 canbe utilized to enable advancement and/or withdrawal of the electrodearray, and the system 400 could control the advancement and/orwithdrawal based on an automated protocol or some other flyby wire typesystem. In the embodiment of FIG. 83, the input device 8320 can be insignal communication directly to the actuator assembly 7720, and/or insignal communication with the control unit 8310.

In an exemplary embodiment, control unit 8310 can correspond to theremote unit 440. That said, in an alternate embodiment, remote unit 440can be a device that is in signal communication with control unit 8310.Indeed, in an exemplary embodiment, input device 8320 can correspond toremote control unit 440.

More particularly, control unit 8310 can be a signal processor or thelike or a personal computer or the like or a mainframe computer or thelike etc., that is configured to receive signals from the ECoG test unit3960 and analyze those signals to evaluate an insertion status of theelectrode array. More particularly, the control unit 83 can beconfigured with software the like to analyze the signals from test unit3960 in real time and/or in near real time as the electrode array isbeing advanced into the cochlea by actuator assembly 7720. The controlunit 8310 analyzes the input from test unit 3960 as the electrode arrayadvanced by the actuator assembly 7720 and evaluates the input todetermine if there exists an undesirable insertion status of theelectrode array and/or evaluates the input to determine if the inputindicates that a scenario could occur or otherwise there exists data inthe input that indicates that a scenario is more likely to occurrelative to other instances where the insertion status of the electrodearray will become undesirable if the electrode array is continued to beadvanced into the cochlea, all other things remaining the same (e.g.,insertion angle/trajectory, etc., which can be automatically changed aswell via—more on this below). In an exemplary embodiment, upon such adetermination, control unit 8310 could halt the advancement of the arrayinto the cochlea by stopping the actuator(s) of actuator assembly 7720and/or could slow the actuator(s) so as to slow rate of advancement ofthe electrode array into the cochlea and/or could reverse theactuator(s) so as to reverse or otherwise retract the electrode arraywithin the cochlea (either partially or fully). In at least someexemplary embodiments, control unit 8310 can be configured to overridethe input from input unit 8320 input by the surgeon or the user or thelike of the system of FIG. 83.

In an exemplary embodiment, the outputs of test unit 3960 corresponds tothe output of test unit 560 detailed above. Alternatively and/or inaddition to this, input into control unit 8310 can flow from othersources. Any input relating to the measurement of voltage associatedwith ECoG measurements into control unit 8310 can be utilized in atleast some exemplary embodiments.

In an exemplary embodiment, control unit 8310 can be configured todetermine, based on the input from test unit 3960, whether the electrodearray has come into contact with the basilar membrane of the cochleaand/or whether there exists an increased likelihood that such contactwill occur, and automatically control the actuator assembly 7720accordingly. In an exemplary embodiment, control unit 8310 does notnecessarily determine that such an insertion status exists or is morelikely to exist, but instead is programmed or otherwise configured so asto control the actuator assembly 7720 according to a predeterminedregime based on the input from the test unit 3960. That is, the controlunit 8310 need not necessarily “understand” otherwise “know” the actualinsertion status or the forecasted insertion status of the electrodearray, but instead need only be able to control the actuator assembly7720 based on the input.

In an exemplary embodiment, control unit 8310 can be configured todetermine, based on the input from test unit 3960, the insertion depthof the electrode array and/or a forecasted insertion depth of theelectrode array, and automatically control the actuator assembly 7720accordingly. In an exemplary embodiment, control unit 8310 does notnecessarily determine the insertion depth or forecasted insertion depth,but instead is programmed or otherwise configured so as to control theactuator assembly 7720 according to a predetermined regime based on theinput from the test unit 3960. That is, the control unit 8310 need notnecessarily “understand” otherwise “know” the actual insertion depth orthe forecasted insertion depth of the electrode array, but instead needonly be able to control the actuator assembly 7720 based on the input.

In an exemplary embodiment, control unit 8310 can be configured todetermine, based on the input from test unit 3960, whether the electrodearray has buckled and/or bent and/or whether there exists an increasedlikelihood that such buckling and/or bending will occur, andautomatically control the actuator assembly 7720 accordingly. In anexemplary embodiment, control unit 8310 does not necessarily determinethat such buckling and/or bending exists or is more likely to exist, butinstead is programmed or otherwise configured so as to control theactuator assembly 7720 according to a predetermined regime based on theinput from the test unit 3960. That is, the control unit 8310 need notnecessarily “understand” otherwise “know” that the electrode array hasactually buckled or will buckle in the future, but instead need only beable to control the actuator assembly 7720 based on the input.

Thus, it can be understood that there is an apparatus that is configuredto receive input indicative of the electrical phenomenon/phenomenainside the recipient, and develop data indicative of a position of theelectrode array within the cochlea based on the input. (It is brieflynoted that unless otherwise specified, the singular term phenomenon alsoincludes a disclosure of the plural thereof, and vis-a-versa, as is alsothe case with the disclosure of data). Still further, such an exemplaryembodiment can be configured to adjust the control of the actuation ofthe actuator based on the develop data indicative of the position of theelectrode array.

To be clear, while the embodiment detailed above is focused oncontrolling the actuator assembly 7720 based on data from the ECoGsystem so as to control the advancement and/or retraction of theelectrode array based on electrical phenomenon/phenomena inside therecipient and/or based on electrical characteristics associated with therecipient, in an alternate embodiment, the system 400 controls one ormore other actuators of the robot apparatus of system 400. These one ormore other actuators can be exclusive from the actuator assembly 7720,or can include the actuator assembly 7720. In this regard, FIG. 84depicts an exemplary robot apparatus 8400, that includes the insertionguide 3900 detailed above with respect to the integration of an ECoGsystem therewith, mounted on arm 8424 utilizing bolts in a mannerconcomitant with that detailed above. In an exemplary embodiment, robotapparatus 8400 has the functionality or otherwise corresponds to that ofthe embodiment of FIG. 75. In this regard, any functionality associatedor otherwise described with respect to the embodiment of FIG. 75corresponds to that of the embodiment of FIG. 84, and vice versa. Inthis exemplary embodiment, the actuator apparatus 7720 is in signalcommunication with unit 3810 via electrical lead 84123. In this regard,signals to and/or from the actuator assembly 7720 can be transmittedto/from the antenna of unit 8310 (in FIG. 84, the “Y” shaped elementsare antennas) and thus communicated via lead 84123. It is briefly notedthat while the embodiment depicted in FIG. 84 utilizes radiofrequencycommunication, in alternate embodiments, the communications can bewired. In an exemplary embodiment both can be utilized.

That said, with the addition of the actuator assembly 7720 and thecommunication components associated there with, insertion guide 3900corresponds to that of FIG. 39.

The robot apparatus 8400 includes a recipient interface 8410 whichentails an arch or halo like structure made out of metal or the likethat extends about the recipient's cranium or other parts of the body.The interface 8410 is bolted to the recipient's head via bolts 8412.That said, in alternate embodiments, other regimes of attachment can beutilized, such as by way of example only and not by way of limitation,strapping the robot to the recipient's head. In this regard, the bodyand interface 8410 can be a flexible strapping can be tightened aboutthe recipient's head.

Housing 8414 is located on top of the interface 8410, as can be seen. Inan exemplary embodiment, housing 8414 includes a battery or the like orotherwise provides an interface to a commercial/utility power supply soas to power the robot apparatus. Still further, in an exemplaryembodiment, housing 8414 can include hydraulic components/connectors tothe extent that the actuators herein utilize hydraulics as opposed toand/or in addition to electrical motors. Mounted on housing 8414 is thefirst actuator 8420, to which arm 8422 is connected in an exemplaryembodiment, actuator 8420 enables the components “downstream” (i.e., thearm connected to the actuator, and the other components to the insertionguide) to articulate in one, two, three, four, five or six degrees offreedom. A second actuator 8420 is attached to the opposite end of thearm 8422, to which is attached a second arm 8422, to which is attached athird actuator 8420, to which is attached to the insertion guideattachment structure 8424. Elements 8422 and 8424 can be metal beams,such as I beams or C beams or box beams, etc. actuators 8420 can beelectrical actuators and/or hydraulic actuators.

As can be seen, each actuator 8420 is provided with an antenna, whichantenna is in signal communication with the control unit 8310. In anexemplary embodiment, control unit 8310 can control the actuation ofthose actuators 8420 so as to position the insertion guide 3900 at thedesired position relative to the recipient. That said, in an alternateembodiment, a single antenna can be utilized, such as one mounted onhousing 8414, which in turn is connected to a decoding device thatoutputs a control signal, such as a driver signal based on the decodedRF signal, to the actuators 8420 (as opposed to each actuator havingsuch a device), which control signals can be provided via a wiredsystem/electrical leads extending from housing 8414 to the actuators.Note also that in some alternate embodiments, control unit 8310 is inwired communication with the actuators, either directly or indirectly,and/or is in wired communication with the decoding device located in thehousing 8414. Any arrangement that can enable control of the robotapparatus in general, and the actuators thereof in particular, viacontrol unit 8310 can be utilized in at least some exemplaryembodiments.

Note also that while the embodiment depicted in FIG. 84 is such that theactuators 8420 must actuate so as to extend the intracochlear portion ofthe insertion guide into the cochlea, in an alternate embodiment, asnoted above, the insertion guide can be mounted on a rail system or thelike, wherein a cylindrical actuator or the like pushes the insertionguide in a linear manner into the cochlea and withdrawals the insertionguide in the linear manner from the cochlea. In an exemplary embodiment,this actuator apparatus can enable one degree of freedom movements ofthe insertion guide, while in other embodiments, this actuator apparatuscan enable two or three or four or five or six degrees of freedom.Indeed, in an exemplary embodiment, this actuator apparatus can enablemovement only in a linear direction, but can enable rotation of theinsertion guide about the longitudinal axis thereof. Any arrangement ofactuator assemblies that will enable the insertion guide to bepositioned relative to the cochlea and/or inserted into the cochlea viarobotic positioning thereof can be utilized in at least some exemplaryembodiments.

As can be seen, the insertion guide 3900 is in signal communication withthe ECoG test unit 3960, which in turn is in signal communication withthe control unit 3810. Note that in some alternate embodiments, signalsfrom the insertion guide are only directed to the control unit 3810,which signals are then relayed to the ECoG test unit 3960 for analysisof the like. Any arrangement of signal communication with the ECoGcomponents of the insertion guide can be utilized in at least someexemplary embodiments.

Still further, note that the interface unit 3820 is depicted in signalcommunication with the antenna of the insertion guide 3900. It isfurther noted that, even though the link between the interface unit 3820is not depicted between every actuator of the robot apparatus 8400, insome exemplary embodiments, the interface unit 3820 is in signalcommunication with all of the actuators of the robot apparatus 8400.Again, the interface unit 8320 can be a unit that provides override orthe like of the system, and/or can be a unit that provides the coursepositioning of the insertion guide 3900, with the control unit 8310providing the fine positioning of the insertion guide 3900.

It is noted that in an exemplary embodiment, the teachings detailedherein can be utilized in conjunction with the sensing unit 432.Briefly, any of the methods detailed herein and/or variations thereofcan be combined with the utilization of the sensing unit 432 and thefunctionalities thereof. Moreover, control of the insertion of theelectrode array via control unit 3810 vis-à-vis the robotic apparatusesdetailed herein and/or variations thereof can be performed inconjunction with data from the sensing unit 432. By way of example onlyand not by way of limitation, the controller 8310 can receive feedbackor otherwise data from the sensing unit 432 during the insertionprocess. Such exemplary feedback could be data indicating a distance ofthe electrode array from a wall of the cochlea, etc. The control unit8310 can evaluate this data and make adjustments to the variousactuators of the robotic system accordingly. By way of example only andnot by way of limitation, if the data from sensing unit 432 indicatesthat continued advancement of the electrode array along a giventrajectory will result in contact of the electrode array with themodiolis wall of the cochlea, control unit 8310 can adjust the angularorientation of the insertion guide to avoid contact with the wall.Alternatively, and/or in addition to this, control unit 8310 can simplyhalt continued advancement of the electrode array in an automatedfashion.

Briefly, as noted above, some exemplary embodiments include anultrasonic transducer mounted on the insertion guide, which ultrasonictransducer is configured to provide ultrasonic imaging or otherwiseprovide data with respect to features within the cochlea of therecipient. By way of example only and not by way of limitation, as amatter of functional and conceptual teachings, aforementioned sensingunit 432 can correspond to the ultrasonic transducer. By way of exampleonly and not by way of limitation, the output from the ultrasonictransducer can be provided to the control unit 8310, which control unitcan evaluate the output from the ultrasonic transducer and control therobotic assembly accordingly.

As will be understood from FIG. 84, an exemplary embodiment includesystems that not only control the insertion and/or retraction of theelectrode array 145 into and out of the cochlea, but also control thepositioning of that electrode array 145, whether utilizing and insertionguide or an electrode array support, relative to the cochlea. In anexemplary embodiment, such can be done at least partially based onelectrical phenomenon of the recipient/based on electricalcharacteristics associated with the recipient. Indeed, such encompassesa scenario where the insertion angle of the electrode array is changedduring the insertion process based on the electrical phenomenon of therecipient/based on electrical characteristics associated with therecipient monitored during the insertion process. In this exemplaryembodiment, the electrical phenomenon/electrical characteristicscorrespond to that sensed or otherwise measured by an ECoG system. Thus,in an exemplary embodiment, there is an apparatus that is configured toinsert the electrode array into a cochlea via controlled actuation of anactuator, wherein the controlled actuation is at least partially basedon ECoG data, wherein the ECoG data is based on the electricalphenomenon of the recipient/based on electrical characteristicsassociated with the recipient. Note that such can also includecontrolling actuation based on other phenomenon such as by way ofexample only and not by way of limitation, resistance to insertion ofthe electrode array measured by a sensor or the like one the robotapparatus, as long as the actuation is controlled at least partiallybased on ECoG data.

It is briefly noted that in at least some exemplary embodiments, thecontrol of the robot and the like or otherwise control the components ofthe system utilized to insert the electrode array can be based onanalysis of the measurements or otherwise data from the measurementelectrodes, etc., of the system as follows. By way of example only andnot by way of limitation, the system can be configured, such as via theutilization of a processor or the like with a programmed algorithm,where the processor is in electrical communication either directly orindirectly with the measurement electrodes of the like, where if ameasured quantity exceeds or is below or is at a predeterminedthreshold, which threshold can be a generic threshold for all recipientsor a specific threshold developed for a specific recipient (thethreshold could be a dynamic threshold—other measurements in real timecould influence the threshold, thus changing the threshold based on theother measurements), or when a directional rate of change of thequantity exceeds a certain threshold or meets a certain threshold or isbelow a certain threshold, the algorithm could automatically control oneor more of the actuators to adjust the insertion process (or thewithdrawal process), which includes halting the insertion process, basedon the various thresholds. (It is noted that while the aforementionedthresholds are directed towards the ECoG system, similar thresholds canbe utilized for the other measurement/telemetry systems detailed hereinand/or variations thereof).

Again, while the embodiment of FIG. 84 is depicted as having componentsof an ECoG system that is part of the robot apparatus 8400, in analternative embodiment, the ECoG system is a separate component from therobot apparatus, which is in signal communication with the robotapparatus and/or the control unit thereof of the system of which therobot apparatus is a part. FIG. 85 presents such an exemplaryembodiment, with the links between the antennas removed for clarity.ECoG system 4044 detailed above is shown in signal communication withcontrol unit 8310. In this exemplary embodiment, ECoG system 4044corresponds to that detailed above with the exception that it isentirely divorced from the insertion guide (save for the communicationbetween ECoG system 4044 and the control unit 8310, to the extent suchis relevant for the purposes of discussion, where control unit 8310 isin signal communication with one or more of the assemblies of the robotapparatus of FIG. 88, such as the actuator assembly 7720. Here, duringinsertion, and/or prior to insertion and/or after insertion, the ECoGsystem 4044 monitors or otherwise measures electrical phenomenonassociated with the recipient/electrical characteristics associated withthe recipient and communicates those measurements and/or the analysisthereof to control unit 8310, which analyzes those signals and developsa control regime for electrode array insertion and/or electrode arraypositioning based on those signals. Note also that in some exemplaryembodiments, the ECoG system can have multiple measurement electrodesand/or signal generators/sources of acoustic signal generation, some ofwhich are part of the robot apparatus, and some of which are separatefrom the robot apparatus, all of which are part of system 4044.Alternatively, these various components of ECoG system can communicatewith test unit 3960. Such can have utilitarian value with respect to ascenario where ECoG measurements are first taken prior to placing theelectrode array near the cochlea and after inserting the electrode arrayinto the cochlea, where it is undesirable to have the insertion guideand/or electrode array support proximate the cochlea. Any device,system, and/or method that will enable controlled movement of theelectrode array relative to the cochlea based on electrical phenomenonassociated with the recipient/based on electrical characteristicsassociated with the recipient can be utilized in at least some exemplaryembodiments.

In view of the above, it is to be understood that in an exemplaryembodiment, the robot apparatus is configured such that the electrodearray support is an insertion tool including an electrode mounted theirone, wherein the apparatus is configured to utilize the electrode toobtain data indicative of the electrical phenomenon of therecipient/data indicative of electrical characteristics associated withthe recipient. Of course, in some alternate embodiments, two or moreelectrodes are mounted on the insertion tool. Still further, in anexemplary embodiment, the actuator is configured to drive the electrodearray relative to the insertion tool to insert the electrode array intothe cochlea, which driving by the actuator is controlled based on theelectrical phenomenon associated with the recipient/based on electricalcharacteristics associated with the recipient.

In view of the above, it can be understood that in an exemplaryembodiment, there is a system, such as the system of 400 detailed above,including a robotic assembly, such as the assembly of FIGS. 84 and 85and 75, wherein the robotic assembly is configured to move the electrodearray relative to the cochlea. In an exemplary embodiment, thiscorresponds to advancing the electrode array into the cochlea and/orwith drawing at least a portion of the electrode array from the cochlea.In an exemplary embodiment, this entails moving the electrode array froma first location outside the cochlea to a second location outside thecochlea. In an exemplary embodiment, this entails changing the angle ofthe electrode array relative to the cochlea, whether such be executedprior to the insertion of the electrode array into the cochlea, duringinsertion of the electrode array into the cochlea (whether such occurswhile the electrode array is being advanced or during a pause inadvancement in the electrode array, etc.). Still further, the systemincludes a control unit such as the control unit 8310 detailed above,configured to receive a recipient physiological data and control therobotic assembly based at least in part on the data. Consistent with theembodiments detailed above, in some embodiments, the physiological datacorresponds to electrical phenomenon associated the recipient/electricalcharacteristics associated with the recipient, such as that which ismeasured by an ECoG system. That said, in other embodiments, otherphysiological data can be utilized. Any physiological data that can beutilized to control the robotic assembly can be utilized in at leastsome exemplary embodiments.

Still further, in an exemplary embodiment, this system is configured toevaluate the recipient physiological data to develop data indicative ofa position of the electrode array relative to the cochlea. Such positioninformation can include the exact position of the electrode array, aswill be described in greater detail below, but can also correspond tothat detailed above, such as determining whether the electrode array hascome into contact with basilar membrane, which corresponds to dataindicative of a position of the electrode array relative to the cochlea.Still further, in an exemplary embodiment, the apparatus is configuredto control the robotic assembly while moving the electrode array intothe cochlea based on the develop data indicative of the position of theelectrode array. As detailed above, such can entail halting theinsertion of the electrode array based on the develop data. Such canalso entail with drawling at least a portion of the electrode array fromthe cochlea based on the develop data. Such can entail slowing and/orspeeding the insertion of the electrode array based on the develop data(e.g., the speed at which the electrode array travels through theinsertion sheath/past the wall of the cochlea at the cochleostomy,etc.). That said, such can entail changing an angle of trajectory of theinsertion of the electrode array, which angle of trajectory can bechanged before insertion of the electrode array into the cochlea, duringthe process of inserting the electrode array to the cochlea (whethersuch occurs while the electrode array is moving into the cochlea orduring a pause in the insertion of the electrode array to the cochlea,etc., and/or while the electrode array is being withdrawn from thecochlea or during a pause thereof etc.), or after the election array isinserted into the cochlea.

Still further, as noted above, some exemplary embodiments of the systemsdetailed herein are utilized in conjunction with systems that can enablethe detection of buckling and/or bending of an array, and/or contact ofthe electrode array with the basilar membrane of the cochlea, etc. asdetailed above, exemplary embodiments can be configured so as to controlone or more of the actuators of the robotic assembly based on theoccurrence of such event (the detection or the indication of theoccurrence of such event, such as based on the ECoG data, etc.), orbased on a forecast that such event is likely to occur if the electrodearray is continued to be inserted into the cochlea according to acurrent insertion regime. Thus, in an exemplary embodiment, the controlunit of the system detailed above can be configured to evaluate therecipient physiological data to determine whether a deleterious arrayinsertion event has occurred or is likely to occur, and the control unitis configured to control the robotic assembly based at least in part onthis evaluation (e.g., to stop or otherwise halt advancement of theelectrode array into the cochlea, reverse advancement, change thetrajectory of the electrode array insertion etc.).

While the embodiments detailed above have focused on ECoG measurementsor the like, in some alternate embodiments, controlled actuation of theactuators of the robotic assembly is at least partially based on voltagemeasurements during electrical stimulation data/voltage measurementsduring energizement of an electrode inside the recipient (either by anelectrode of a cochlear electrode array and/or by the electrode(s) ofthe insertion guide (sometimes referred to as voltage tomography). In anexemplary embodiment, the voltage measurement during electricalstimulation/relating to energizement of an electrode inside therecipient data is based on the electrical phenomenon of therecipient/based on electrical characteristics associated with therecipient. In this regard, at least some instances are such where thevoltage measurements during electrical stimulation/energizement of anelectrode inside the recipient is based at least in part on theelectrical phenomenon of the recipient/based at least in part onelectrical characteristics associated with the recipient. Such can haveutilitarian value with respect to identifying a tip fold-over condition,and angular insertion depth of the electrode array, a linear or absoluteinsertion depth of the electrode array, a relative location of theelectrode array to a wall of the cochlea, and occurrence of twisting ofthe array, and/or a determination of a punctual of the basilar membrane.Other occurrences can also be identified utilizing such data.

Briefly, while the embodiment of FIG. 64 detailed above has beenpresented in terms of utilizing an electrode on the insertion guide,some exemplary embodiments are such that the voltage measurements areachieved utilizing only the electrodes of the electrode array. In thisregard, while some embodiments of the systems detailed herein utilizingthe robotic apparatus utilize an electrode of the insertion guide toobtain at least some of the voltage measurements so that the actuatorscan be controlled based on those measurements, some alternateembodiments include utilizing electrodes of the electrode array toobtain those voltage measurements. Thus, the following is somewhatdifferent from the embodiment detailed above with respect to FIG. 64,although similarities will be seen as well. To be clear, method 300 ofthe embodiment of FIG. 64 can be utilized in conjunction with a roboticapparatus of the like, where at least some of the results of executingthat method can be utilized to control the actuators of the roboticassembly. However, the following will be focused on a different mannerof obtaining the voltage measurements, which measurements are utilizedat least in part to control the actuators.

FIG. 86 is a flowchart of a method 10300 for monitoring the physicalstate of the electrode array (sometimes herein referred to as astimulating assembly) through the use of localized stimulation, wherethe data that results from executing that method can be used to controlthe actuator(s) of the robot assembly. The method 10300 of FIG. 86 issometimes referred to herein as a localized monitoring method as themethod uses the delivery of localized stimulation (i.e., currentsignals) to induce voltages at a plurality of other contacts.

Method 10300 begins at 10302 where stimulation (i.e., one or morecurrent signals) is delivered/sourced at a selected intra-cochlearelectrode (sometimes referred to herein as contact, as noted above). Inone specific example, the stimulation is delivered at the mostdistal/apical electrode/contact and is sunk at the second most distalelectrode/contact (i.e., the contact adjacent to contact). Theelectrode/contact that delivers the current signals is sometimesreferred to herein as the “stimulating” or “source” electrode/contactand the electrode/contact that sinks the current signals is sometimesreferred to herein as the “return” electrode/contact. Additionally, thetwo electrodes/contacts between which the stimulation is delivered(i.e., the most distal/apical contacts in the embodiment of FIG. 86) arecollectively referred to herein as a “stimulating pair.” The remainingelectrodes/contacts that are not part of the stimulating pair aredisconnected from the system ground (i.e., are electrically “floating”).

In general, two intra-cochlear electrodes/contacts are selected fordelivery of the stimulation. However, alternative embodiments may useextra-cochlear electrodes/contact to source/sink current. Additionally,it is to be that the use of the most distal electrodes/contacts forsourcing/sinking the current is illustrative and otherelectrodes/contacts could be used in alternative embodiments.

During insertion of the electrode array into the recipient's cochlea,the scala tympani is typically substantially filled with a conductivefluid known as perilymph. As such, when current signals are delivered atone of the intra-cochlear electrodes/contacts, at least a portion of thecurrent will spread through the perilymph. The flow of the currentthrough the perilymph will cause the generation of voltages at the otherintra-cochlear stimulating electrodes/contacts. That is, although thestimulus is localized, due to the conductive perilymph the electricfield spreads and induces voltage at the other electrodes/contacts.

At 10304, following the delivery of the current signals at the givencontact, voltage measurements are performed at a selected number ofother intra-cochlear contacts. That is, the voltage induced at theselected other electrodes/contacts as a result of the delivery of thecurrent signals at the measurement contact are measured. (The contactsat which the voltages are measured are sometimes referred to herein as“measurement” contacts or “measurement electrodes.”) In the embodimentof FIG. 86, the measurement contacts may include any of thecontacts/electrodes.

In certain circumstances, the cochlear implant associated with theelectrode array is configured to make a plurality of voltagemeasurements at substantially the same time in response to the deliveryof stimulation. In such embodiments, a single set of localized currentsignals is applied and the voltage induced at a selected number of themeasurement electrodes/contacts is measured substantially simultaneouslyat the measurement electrodes/contacts. In other embodiments, thecochlear implant is configured to measure the voltage at a singleelectrode/contact in response to the delivery of a set of currentsignals. In such embodiments, a plurality of sets of localized currentsignals is applied in sequence at a given electrode, and a voltage ismeasured at a different electrode/contact after each sequentialstimulation. As such, in the context of FIG. 86, the delivery of singlestimulation pattern may refer to the delivery of one set of currentsignals (with subsequent substantially simultaneous measurement at eachof the selected measurement contacts) or the sequential delivery ofplurality of sets of current signals (with subsequent measurement at oneof the selected measurement contacts after each set of current signalsare delivered).

As noted above, stimulation delivered at a contact will have an effecton the other contacts, and the effect may depend on a number of factors.However, a primary factor that controls the effects of stimulation isthe distance between the stimulating contact and the measurementcontact. For example, in the embodiment of FIG. 86, when stimulation isdelivered at a contact/electrode, the voltage measured at other contactsshould be increasingly smaller for contacts positioned farther from thestimulating contact. Therefore, at 10306 of FIG. 86, the inducedvoltages measured at each of the measurement contacts in response to thesingle stimulation pattern are evaluated relative to one another todetermine the relative distance between the stimulating contact and eachof the measurement contacts (i.e., the contacts at which voltages aremeasured). An evaluation of the voltages relative to one another enablesthe determination of the physical state of the electrode array withinthe cochlea. Also as described further below, based on the evaluation ofmeasurements relative to one another, the cochlear implant or aconnected device may generate feedback to a surgeon or other user thatprovides information about the physical state of the electrode arrayand/or the occurrence of an adverse event. Because the current must pastthrough the perilymph, and the perilymph influences the voltage recordedas the measurement electrode(s), the voltage is thus at least partiallybased on electrical phenomenon of the recipient/based on electricalcharacteristics associated with the recipient/electricalphenomenon/characteristics inside the recipient. To be clear, theperilymph is not the only feature that influences voltage. In thisregard, the voltage difference is a function of the resistance of themedium between two contacts. In an exemplary embodiment, most of thecurrent will flow through the perilymph, and the conductive the thereofwill affect the voltage drop between the two contacts. However, theresistance of alternate current paths, such as through bone and nerveand blood vessels, will also contribute. In this regard, the voltage isalso thus at least partially based on electrical phenomenon of therecipient/based on electrical characteristics associated with therecipient/inside the recipient, etc. While it is noted that there arefeatures such as interface impedance, etc., at the service of thestimulating contact, that can impact the voltage, because the voltagedrop between the contacts is still at least partially (in mostinstances, primarily) based on the perilymph and/or tissue, the voltageis thus at least partially based on electrical phenomenon associatedwith the recipient/based on electrical characteristics associated withthe recipient/inside the recipient.

Thus, the robotic apparatuses detailed herein and variations thereof canbe utilized in conjunction with the electrode array of the cochlearimplant to evaluate or otherwise determine the status of an electrodearray within the cochlea as detailed in the '255 patent application. Inan exemplary embodiment, this can be done while the electrode array isbeing inserted into the cochlea. In an exemplary embodiment, the system400 is configured to receive data from a system configured to implementthe teachings of the '255 patent application, such as by way of exampleonly and not by way of limitation, a cochlear implant having thecapabilities to do so, as is detailed by way of example in the '255patent application. Based on this data from the system implementing theteachings of the '255 patent application relating to voltagemeasurements, data relating to a status of the electrode array withinthe cochlea can be evaluated, and based on this data, the actuators ofthe robotic apparatus are controlled during the cochlear electrode arrayinsertion process.

In an exemplary embodiment, voltages measured during execution of thelocalized monitoring method 10300 during a typical normal insertion(i.e., where no adverse events occur with respect to the electrodearray) will have a typical pattern or at least will follow a typicaltrend (as is detailed in the '255 patent application). Conversely,voltages measured during execution of the localized monitoring method10300 during insertion of a cochlear electrode array where an adverseevent occurs will result in a deviation from this typical patterntypical trend (as is detailed in the '255 patent application). By way ofexample only and not by way of limitation, the voltages measured can beutilized to determine whether or not a tip fold-over occurrence hasoccurred, and also in some embodiments, whether a tip fold-over islikely to occur or otherwise forecast that such a scenario will occur oreven may occur. Still further by way of example only and not by way oflimitation, the voltages measured can be utilized to determine whetheror not a deformation (an undesirable deformation) of the electrode arrayhas occurred, and also in some embodiments, whether such deformation islikely to occur or otherwise forecast that such a scenario will occur oreven may occur. These exemplary scenarios are specifically detailed inthe aforementioned '255 patent application. It is noted that in somealternate embodiments, the voltage measurements achieved by implementingthe teachings of the '255 patent application can be utilized todetermine other features associated with the status of the electrodearray as it is being inserted into the cochlea or after it is insertedinto the cochlea. In some exemplary embodiments, any feature of theelectrode array relating to a status thereof as it is being insertedinto the cochlea or after it is inserted into the cochlea that can beidentified or otherwise evaluated or estimated based on measurements ofvoltage as detailed herein that can enable a status of the electrodearray to be determined or otherwise forecasted or estimated, can beutilized in at least some exemplary embodiments.

To this end, FIG. 87 depicts an exemplary system including the robotapparatus as shown, along with voltage measurement device 8710 which isin signal communication with the control unit 8310. In an exemplaryembodiment, voltage measurement device 8710 corresponds to a cochlearimplant configured to execute method 10300 detailed above, andcommunicate the results of that method to control unit 8310. In thisregard, the voltage measurement device can correspond to areceiver/stimulator of a cochlear implant, which has an inductance coil.The inductance coil can be placed into signal communication with anotherinductance coil that in turn is in signal communication with controlunit 8310. Control unit 8310 can be configured to activate thereceiver/stimulator of the cochlear implant to execute method 3000. Inan alternative embodiment, the receiver/stimulator of the cochlearimplant can execute such autonomously. The receiver/stimulator of thecochlear implant, represented by the measurement device 8710 infunctional terms as seen in FIG. 87, transmits the data based on orotherwise resulting from the execution of method 10300 to the controlunit 8310. Control unit 8310 analyzes the data, and, at least based inpart on that data, controls the actuators of the robot assembly.

To be clear, FIG. 88 depicts an exemplary high-level diagram of areceiver/stimulator 8710 of a cochlear implant, corresponding to themeasurement device 8710 of FIG. 88 in an exemplary embodiment, lookingdownward. As can be seen, the receiver/stimulator 8710 includes a magnet160 that is surrounded by a coil 137 that is in two-way communication(although in other embodiments, the communication is one-way) with astimulator unit 122, which in turn is in communication with theelectrode array 145. Receiver/stimulator 8710 further includes acochlear stimulator unit 122, in signal communication with the coil 137.The coil 137 and the stimulator unit 122 are encased in silicon asrepresented by element 199. FIG. 89 depicts an exemplary embodiment ofthe receiver/stimulator 8710 in signal communication with the controlunit 8310 via electrical lead that extends from an inductance coildevice 7444 having coil 7410 about a magnet 7474 as can be seen. Theinductance coil device 7444 communicates via an inductance field withthe inductance coil of the receiver/stimulator 8710 so that the dataacquired by the implantable component 8710 can be transferred to thecontrol unit 8310.

Note also that in at least some alternate exemplary embodiments, controlunit 8310 can communicate with the so-called “hard ball” referenceelectrode of the implantable component of the cochlear implant so as toenable communication of data from the receiver/stimulator 8710 tocontrol unit 8310 and/or vice versa.

It is noted that in the embodiment of FIG. 89, control unit 8310 is insignal communication with the various other components as detailedherein, which components are not depicted in FIG. 89 for purposes ofclarity.

To be clear, the various other methods of the '255 patent applicationcan be executed by the measurement unit 8710, and the results thereofcan be used as a basis to control the actuators of the robot assembly.By way of example only and not by way of limitation, the bipolar voltagemeasurement techniques detailed in that patent application can beutilized in at least some exemplary embodiments. Indeed, the teachingsof that patent application are such that those teachings can enable adetermination that an adverse event associated with the electrode arrayhas occurred or is about to occur, as is detailed in that patentapplication. Further, measurement unit 8710 can correspond to thecochlear implant 700 of the '255 patent application, which cochlearimplant is configured to monitor the physical state of the electrodearray according to the teachings of that patent application.

To be clear, while the just detailed exemplary embodiments have beendirected toward utilizing a device that is completely separate from therobotic apparatus in general, and the insertion guide in particular ofsystem 400, in some alternate embodiments, the embodiments associatedwith method 300 detailed above, where the electrode and/or othercomponents are part of the insertion guide in particular, and the robotapparatus in general, can be utilized to obtain the voltage measurementsas well. Any device, system, and/or method that can enable the voltagemeasurements to implement the teachings detailed herein and/orvariations thereof in conjunction with or otherwise based on theteachings of the '255 patent application, can be utilized at least insome exemplary embodiments. Thus, in an exemplary embodiment, method 300can be executed in conjunction with utilization of a robotic assembly orthe other systems detailed herein, so as to obtain data upon which tobase the control of the actuators, etc., according to an exemplaryembodiment.

Thus, an exemplary embodiment includes a robotic apparatus as detailedherein and/or variations thereof, along with a control unit, such ascontrol unit 8310, which control unit is configured to provide acontrolled actuation of the actuator at least partially based on theelectrical phenomenon/at least partially based on electricalcharacteristics associated with the recipient. The system of which therobotic apparatus is a part is configured to place the control unit intosignal communication with a cochlear implant (e.g., via the embodimentof FIG. of FIG. 89) of which the electrode array is a part. The cochlearimplant is configured to obtain data indicative of the electricalphenomenon of the recipient/electrical characteristics associated withthe recipient (e.g., configured to execute method 10300, etc.). Thesystem of which the robotic apparatus is a part is also configured toconvey data based on the obtained data to the control unit via theestablished signal communication with the cochlear implant so that thecontrol unit can provide the controlled actuation of the actuator atleast partially based on the electrical phenomenon/electricalcharacteristics.

Corollary to the above, in an exemplary embodiment, with respect to thesystem including a control unit configured to receive data based on datarelated to electrical phenomenon inside the recipient, control unit 8310is configured to receive telemetry from an implantable system, such asthe cochlear implant, of which the electrode array is a part. In such anexemplary embodiment, the data based on the data based on electricalphenomenon inside the recipient is based on the telemetry received bythe control unit 8310 from the implantable system (cochlear implant).

Still further, it is noted that some alternate embodiments of therobotic apparatuses and systems detailed herein can be utilized withmethods and apparatuses associated with obtaining impedance measurementswithin a recipient, which methods can be used to determine an insertiondepth of the electrode array. For example, the methods of U.S. patentapplication Ser. No. 14/843,259 can be utilized in conjunction with theteachings detailed herein, as noted above. While the teachings detailedabove associated with the '259 patent application are directed towardsutilizing an electrode or the like that is mounted on the insertionguide or otherwise is part of the robotic apparatus, in some otherembodiments, as is the case with the '255 patent application, theteachings detailed herein can be utilized such that the components thatare utilized to execute the teachings of the '259 patent are completelyseparate from the robotic apparatus save for the communication with suchcomponents and the control unit of the system 400. In this regard, FIG.90 is a flowchart of a first intra-operative method 3000 for settingand/or determining an angular insertion depth of the cochlear electrodearray. FIG. 90 illustrates a real-time method that enables thedetermination of the current/present (i.e., actual) angular insertiondepth of the electrode array within the cochlea. Method 3000 begins at3020 where the electrode array is at least partially inserted into thecochlea. At 3040, during insertion of the electrode array into thecochlea, the impedance between different pairs of intra-cochlearcontacts of the electrode array is measured and used to determine theangular insertion depth of the stimulating assembly. In one embodiment,to measure the impedance between two intra-cochlear contacts, bipolarelectrical stimulation (i.e., one or more bipolar current signals) isrepeatedly delivered between a first intra-cochlear contact and a secondintra-cochlear contact. After the delivery of each set of bipolarstimulation between the first and second intra-cochlear contacts, theimpedance between the first and second contacts is measured (e.g., atthe second intra-cochlear contact). It is to be appreciated thatimpedance measurements are made between two points, thus the impedancemay be “measured” at either of the two points (i.e., it is a relativemeasurement between those two points). However, merely for ease ofillustration of certain embodiments presented herein, the return contactof the stimulating pair is sometimes referred to herein as a“measurement” contact.

In general, the impedance between two intra-cochlear contacts in astimulating pair can be correlated to their physical proximity with oneanother and their location in the cochlea. The physically closer thecontacts of the stimulating pair are to one another, the lower theimpedance that will be measured between the contacts. At 3060, againwhile inserting the electrode array, the impedance-to-proximityrelationship is used to evaluate the plurality of impedance measurementsrelative to one another to determine the relative proximity between thetwo or more intra-cochlear contacts and thus determine the real-time(current/present) angular insertion depth of the electrode array. Asdescribed further below, the method includes the selection one or moresets/pairs of intra-cochlear contacts for impedance measurement thathave a relationship to one another that enables the angular insertiondepth of the electrode array to be determined from the relativeproximity of the one or more pairs of intra-cochlear contacts. Incertain embodiments of FIG. 90, the two or more intra-cochlear contactsselected for impedance measurement comprise two specific (staticcontacts) that have a maximum physical separation when the angularinsertion depth of the electrode array is 180° (i.e., the distal end ofthe electrode array is inserted to 180°), and a minimum physicalseparation when the angular insertion depth of the electrode array is360° (i.e., the distal end of the electrode array is inserted to 360°).This relationship between contacts having a maximum and minimumseparation arrangement at the specific 180° and 360° points is referredto herein as an angular proximity relationship.

Depending on, for example, the shape, size, length, etc. of astimulating assembly, different contacts may have an angular proximityrelationship. As such, different stimulating pairs of contacts may beused in accordance with different embodiments to determine the angularinsertion depth of the electrode array. Therefore, in certainembodiments, the method includes determining and selecting the one ormore pairs of intra-cochlea contacts that are believed to have a correctangular proximity relationship.

For example, as is detailed in the '259 patent application, in oneillustrative embodiment, the most distal/apical contact and the mostproximal/basal contact have an angular proximity relationship thatenables the use of impedance measurements between these two contacts todetermine the angular insertion of the electrode array. Bipolarstimulation is delivered between various contacts (e.g., the mostproximal and the most distal) and the impedance between the contacts ismeasured. This process is repeated over a period of time to produce aplurality of impedance measurements. These impedance measurements areplotted as an impedance curve. The measurement of the impedance betweenthe various contacts begins at a point along the impedance curve that iscreated. The measurement of the impedance between contacts may begin,for example, when a first contact enters the cochlea through acochleostomy, and may continue while the electrode array is insertedinto the cochlea. In general, the contacts experience a significantimpedance change after entering into the cochlea (e.g., due to immersionin the conductive perilymph). As such, the system can monitor theimpedance at a given contact to determine when the contact enters thecochlea 130.

Utilizing the measured impedance plotted against the angular insertiondepth of the electrode array, it will typically be seen that theimpedance rises from a starting point to a first peak/maximum at asecond point. The impedance subsequently falls to a minimum at a thirdpoint, then again rises to second peak/maximum at a fourth point.Because the impedance between the pertinent contacts is a maximum at thesecond point, the second point indicates that the electrode array hasbeen inserted 180 degrees (e.g., the distal most and proximal mostcontacts are at the maximum possible distance from one another withincochlea). Stated differently, this first maximum point indicates thatthe distal end of the electrode array has reached 180° point, while themost proximate contact is relatively close to 0° point.

Similarly, because the impedance between the most distal and the mostproximal contacts is a minimum at the third point, the third pointindicates that the electrode array has been inserted 360 degrees (i.e.,the distal most and proximal most contacts are at the minimum possibledistance from one another within cochlea). Stated differently, thisminimum point indicates that the distal end of electrode array hasreached 360° point, while the most proximal contact is located withinthe basal region of cochlea substantially close to 360° point (i.e., thedistal most and proximal most contacts are physically close together,but separated by a section of the modiolus). Continuing with referenceto the '259 patent application, the second maximum of the impedancecurve indicates a location of distal end of the electrode array at whichthe impedance between the distal most contact and the proximal mostcontact is a second maximum. That is, the electrode array has beeninserted another 180 degrees from the minimum point such that theelectrode array is at an angular insertion depth of 540 degrees.

In summary, by monitoring impedance between two selected contacts andevaluating the impedance curve or other data associated therewith orother data, the relative positions of the electrodes can be determined,which can provide information indicative of the relative positions ofthe electrodes within the cochlea, and thus the insertion angle depth.In further embodiments of FIG. 90, the impedances between differentpairs of contacts may be monitored and simultaneously evaluated todetermine the angular insertion depth of the electrode array. Forexample, a plaque can be created with respect to a curve of impedancemeasured between a distal end or a proximal contact and a middle contact(e.g., contact 12 of 24 contacts) during insertion the electrode array.The plot can have a vertical (Y) axis that represents the measuredimpedance and a horizontal (X) axis that represents contacts.

It is noted that in some exemplary embodiments, plots can be made thatillustrate measured impedance values between two specific contacts overa period of time, and thus the positions of the various electrodes canbe determined on a temporal basis. However, the data can also bepresented in terms of illustrating the impedance values measured betweena distal most and/or a proximal most electrode array and the contactsbetween such electrode and the middle electrode thereof (e.g., electrode12) at a particular instant while the electrode array is at a specificlocation. The impedance curve may be generated by sequentiallydelivering bipolar stimulation between a stimulating contact at thedistal most location of the proximal most location and each of thereturn contacts, and measuring the impedance at each contact (i.e.,sequentially changing the return contact for the bipolar stimulationmeasuring the impedance between the present return contact and thestimulating contact). Some exemplary embodiments include utilization ofany of the teachings detailed in the '259 patent application withrespect to obtaining data indicative of the angular insertion depth ofthe electrode array. Thus, the bipolar stimulation features associatedwith that patent application can be utilized in at least some exemplaryembodiments.

It is noted that in some alternate embodiments, the impedancemeasurements achieved by implementing the teachings of the '259 patentapplication can be utilized to determine other features associated withthe status of the electrode array as it is being inserted into thecochlea or after it is inserted into the cochlea. In some exemplaryembodiments, any feature of the electrode array relating to a statusthereof as it is being inserted into the cochlea or after it is insertedinto the cochlea that can be identified or otherwise evaluated orestimated based on measurements of impedance as detailed herein that canenable a status of the electrode array to be determined or otherwiseforecasted or estimated, can be utilized in at least some exemplaryembodiments.

To this end, with respect to FIG. 87, which as noted above, depicts anexemplary system including the robot apparatus as shown, along withvoltage measurement device 8710 which is in signal communication withthe control unit 8310. It is noted that in an alternate embodiment,device 8710 is an impedance measurement device. In an exemplaryembodiment, device 8710 can be both a voltage measurement device and animpedance measurement device. In an exemplary embodiment, device 8710 inthe form of an impedance measurement device (or a voltage and impedancemeasurement device) corresponds to a cochlear implant configured toexecute method 3000 detailed above, and communicate the results of thatmethod to control unit 8310. In this regard, the impedance measurementdevice can correspond to a receiver/stimulator of a cochlear implant,which has an inductance coil and can be utilized as detailed above,albeit with respect to measuring impedance and conveying suchmeasurements to the control unit 8310. Corollary to this is that controlunit 8310 can be configured to activate the receiver/stimulator of thecochlear implant to execute method 3000. In an alternative embodiment,the receiver/stimulator of the cochlear implant can execute suchautonomously. The receiver/stimulator of the cochlear implant,represented by the measurement device 8710 in functional terms as seenin FIG. 87, transmits the data based on one or otherwise resulting fromthe execution of method 3000 to the control unit 8310. Control unit 8310analyzes the data, and at least based in part on that data, controls theactuators of the robot assembly.

To be clear, the various other methods of the '259 patent applicationcan be executed by the measurement unit 8710, and the results thereofcan be used as a basis to control the actuators of the robot assembly.By way of example only and not by way of limitation, the bipolarstimulation techniques detailed in that patent application can beutilized in at least some exemplary embodiments. Further, measurementunit 8710 can correspond to the cochlear implant of the '259 patentapplication, which cochlear implant is configured to monitor thelocation of the electrode array according to the teachings of thatpatent application.

To be clear, while the just detailed exemplary embodiments have beendirected toward utilizing a device that is completely separate from therobotic apparatus in general, and the insertion guide in particular ofsystem 400, in some alternate embodiments, the embodiments associatedwith method 1300 detailed above, where the electrode and/or othercomponents are part of the insertion guide in particular, and the robotapparatus in general, can be utilized to obtain the impedancemeasurements as well. Any device, system, and/or method that can enablethe impedance measurements to implement the teachings detailed hereinand/or variations thereof in conjunction with or otherwise based on theteachings of the '259 patent application can be utilized in at leastsome exemplary embodiments. Thus, in an exemplary embodiment, method1300 can be executed in conjunction with utilization of a roboticassembly or the other systems detailed herein, so as to obtain data uponwhich to base the control of the actuators etc., according to anexemplary embodiment.

Thus, an exemplary embodiment includes a robotic apparatus as detailedherein and/or variations thereof, along with a control unit, such ascontrol unit 8310, which control unit is configured to provide acontrolled actuation of the actuator at least partially based on theelectrical phenomenon/based on the electrical characteristics. Thesystem of which the robotic apparatus is a part is configured to placethe control unit into signal communication with a cochlear implant(e.g., via the embodiment of FIG. 89) of which the electrode array is apart. The cochlear implant is configured to obtain data indicative ofthe electrical phenomenon of the recipient the electricalcharacteristics of the recipient (e.g., configured to execute method3000, etc.). The system of which the robotic apparatus is a part is alsoconfigured to convey data based on the obtained data to the control unitvia the established signal communication with the cochlear implant sothat the control unit can provide the controlled actuation of theactuator at least partially based on the electricalphenomenon/electrical characteristics.

Still further with respect to the embodiments detailed above associatedwith an apparatus configured to control actuation of actuators at leastpartially based on electrical phenomenon of the recipient/electricalcharacteristics of the recipient, in an exemplary embodiment, thecontrolled actuation is at least partially based on evoked compoundaction potentials (ECAP)—sometimes referred to in the art as NRT—data.In an exemplary embodiment, this ECAP data is based at least in part onthe electrical phenomenon of the recipient/electrical characteristics ofthe recipient. In an exemplary embodiment, the ECAP data is utilized todetermine one or more of the conditions of the electrode array detailedherein and/or variations thereof (tip fold over, insertion angle depth,distance of the electrode array from the modiolis wall, etc.). To thisend, with respect to FIG. 87, which as noted above, depicts an exemplarysystem including the robot apparatus as shown, along with voltagemeasurement device 8710 which is in signal communication with thecontrol unit 8310. It is noted that in an alternate embodiment, device8710 is an ECAP device. In an exemplary embodiment, device 8710 can be avoltage measurement device and an impedance measurement device(generically speaking) and an ECAP device. In an exemplary embodiment,device 8710 is in the form of a cochlear implant configured to executeECAP measurements to obtain the ECAP data, which cochlear implant isconfigured to communicate the results of such measurements to controlunit 8310. In this regard, the ECAP measurement device/ECAP datacollection device can correspond to a receiver/stimulator of a cochlearimplant, which has an inductance coil and can be utilized as detailedabove, albeit with respect to measuring ECAP or otherwise developing orcollecting ECAP data and conveying such measurements to the control unit8310. Corollary to this is that control unit 8310 can be configured toactivate the receiver/stimulator of the cochlear implant to execute themeasurements/the collection of the data. In an alternative embodiment,the receiver/stimulator of the cochlear implant can execute suchautonomously. The receiver/stimulator of the cochlear implant,represented by the ECAP measurement device 8710 in functional terms asseen in FIG. 87, transmits the data based on or otherwise resulting fromthe execution of ECAP measurements to the control unit 8310. Controlunit 8310 analyzes the data, and at least based in part on that data,controls the actuators of the robot assembly.

To be clear, while the just-detailed exemplary embodiments have beendirected toward utilizing a device that is completely separate from therobotic apparatus in general, and the insertion guide in particular ofsystem 400, in some alternate embodiments, the ECAP data is collected orotherwise measured with components part of the insertion guide inparticular, and the robot apparatus in general. Any device, systemand/or method that can enable ECAP measurements and/or the collection ofECAP data to implement the teachings detailed herein and/or variationsthereof can be utilized in at least some exemplary embodiments so as toobtain data associated with a condition or otherwise location of theelectrode array or otherwise control the actuators of the robotapparatus.

Concomitant with the teachings detailed above, FIG. 91 depicts anexemplary flowchart for an exemplary method 9100. Method 9100 includesmethod action 9110, which entails advancing at least a first portion ofan electrode array into a cochlea of a recipient during a first temporalperiod at least partially assisted by activation of an actuator thatmoves the electrode array. In an exemplary embodiment, the actuator cancorrespond to the actuator of the actuator assembly 7720 detailed abovewhere actuators of the other embodiments of the actuator assembly'sdetailed herein and/or variations thereof. Method 9100 further includesmethod action 9120, which entails monitoring and electricalphenomenon/electrical characteristics within the recipient at least oneof during the first temporal period or during a second temporal periodsubsequent to the first temporal period. In an exemplary embodiment, theelectrical phenomenon/electrical characteristics monitored cancorrespond to any of the electrical phenomenon/characteristics detailedherein. It is noted that in at least some exemplary embodiments, theelectrical phenomenon/characteristics is monitored while the electrodearray is being advanced during the first temporal period, in somealternate embodiments, the electrical phenomenon/characteristics ismonitored after the electrode array has been advanced during the firsttemporal period. In an exemplary embodiment, the second temporal periodcan correspond to a temporal period where the electrode array is notbeing advanced and/or not being retracted. By way of example only andnot by way of limitation, method action 9100 can be executed in a mannerhaving discrete advancement steps. For example, the electrode array canbe advanced, then stopped, then the electricalphenomenon/characteristics could be monitored, then the electrode arraycan begin to be advanced again, then stopped, then the electricalphenomenon/characteristics can be monitored again, then the electrodearray can begin to be advanced again, then stopped, then the electricalphenomenon/characteristics can be monitored yet again, and so on. Notealso that the electrical phenomenon characteristics can be monitoredduring the entire period (i.e., while the electrode array is beingadvanced and while the electrode array is stationary). In an exemplaryembodiment, the method 9100 is executed in a manner analogous to thelook-shoot-look way of air to air combat.

Note also that in some alternate exemplary embodiments, the electrodearray can be advanced all the time, but the phenomenon is monitored onlysome of the time. Note also that depending on the system, differentelectrical phenomenon/characteristics can be monitored at differenttimes. By way of example only and not by way of limitation, a scenariocan exist where during a first temporal period, the ECoG measurementsare being taken, during a second temporal period, the voltagemeasurements are being taken, and during a third temporal period, theECAP measurements are being taken. Those three periods could beproceeded or proceeded by advancement of the electrode array. Thus, inan exemplary embodiment, method 9100 is executed by advancing theelectrode array by a first amount, then stopping, then taking the ECOPmeasurements, the voltage measurements, and then the ECAP measurements(in any order), and then advancing the electrode array beyond the firstamount by another amount, and then taking the measurements again, and soon. Again, the measurements can be taken in any order, and thosemeasurements can be taken while the electrode array is being advancedand/or retracted.

Still with reference to method 9100 of FIG. 91, method 9100 furtherincludes method action 9130, which entails controlling the actuatorbased on the action of monitoring in method action 9120. As detailedabove, in an exemplary embodiment, the actuator can be halted and/orreversed in a scenario where the measurements indicate that adeleterious result will occur by continuing advancements of theelectrode array into the cochlea. Alternatively, and/or in addition tothis, the rate of advancement can be increased and/or decreased based onthe measurements.

Note that in an exemplary embodiment of method 9100, the action ofcontrolling the actuator based in the action of monitoring can beexecuted by a human. By way of example only and not by way oflimitation, as a result of method action 9120, an indicator or the likecan be provided to the surgeon or the like or the healthcareprofessional operating the user input device of the system 400. In anexemplary embodiment, the surgeon or the like executes method action9130. That said, in an alternate embodiment, method action 9130 can beexecuted by the control unit 8310 detailed above, or variations thereof.

As noted above, the status of the electrode array can be evaluatedutilizing the monitored electrical phenomenon. By way of example onlyand not by way of limitation, there is an exemplary method asrepresented by the flowchart of FIG. 92. Specifically, FIG. 92 presentsa flowchart for method 9200. Method 9200 includes method action 9210,which entails executing method 9100. Method 9120 further includes methodaction 9220, which entails determining that a deleterious event hasoccurred with respect to the electrode array based on the monitoredelectrical phenomenon/characteristics. Method 9200 further includesmethod action 9230, which entails controlling the actuator to at leastone of halt advancement of the electrode array or retracted theelectrode array based on the determined deleterious event. In thisregard, in an exemplary embodiment, a species of method action 9220 canentail determining that an electrode array tip fold-over has occurredbased on the monitored electrical phenomenon characteristics. Also, anexemplary species of method action 9220 can entail determining that theelectrode array has buckled. Alternatively, and/or in addition to this,an exemplary species of method action 9220 can entail determining thatthe electrode array has come into contact with a wall of the cochleathat is not desired to contact. By way of example only and not by way oflimitation, in an exemplary embodiment, the deleterious event cancorrespond to the electrode array coming into contact with the modioluswall during advancement of the electrode array. Note also that in somealternate exemplary embodiments, method action 9220 can alternativelycorrespond to determining that the deleterious event will occur insteadof determining that the event has occurred. That said, in an alternateembodiment, method action 920 can entail determining both.

Also, in an exemplary species of method action 9220, method action 920can entail determining at least one of whether the electrode array hastwisted or will twist based on the monitored electricalphenomenon/characteristics.

As is to be understood in view of the above, in an exemplary embodiment,method 9100 further includes utilizing at least one of ECoG, ECAPmeasurement or voltage measurements during the first temporal periodand/or the second temporal period to monitor the electricalphenomenon/characteristics. In an exemplary embodiment, any of thedevices and/or systems detailed herein and/or variations thereof can beutilized in at least some exemplary embodiments.

FIG. 93 depicts an exemplary flowchart for an exemplary method 9300.Method 9300 includes method action 9310, which entails executing method9100. Method 9300 further includes method action 9320, which entailsdetermining a status of the electrode array based on the monitoredelectrical phenomenon/characteristics. Method action 9330 entailscontrolling the actuator to at least one of halt advancement of theelectrode array or retract the electrode array based on thedetermination of method action 9320. In an exemplary species of methodaction 9320, the status that is determined is an angular insertion depthof the electrode array. In an exemplary species of method action 9320,the status that is determined is a proximity of the electrode array to awall of the cochlea.

FIG. 94 depicts an exemplary flowchart for another exemplary method,method 9400. Method 9400 includes method action 9410, which entailsexecuting method 9100. Method 9400 includes method action 9420, whichentails determining a status of the electrode array based on themonitored electrical phenomenon/characteristics. Method 9400 furtherincludes method action 9430, which entails controlling at least one ofthe actuator or another actuator to change a trajectory of the electrodearray insertion based on the determination. As noted above, someexemplary scenarios can exist where the deleterious result of anelectrode array piercing a wall of the cochlea (other than where thecochleostomy is present) can occur as a result of the advancementprocess of the electrode array. Accordingly, an exemplary embodiment ofmethod action 9320 can entail that the electrode array is continued tobe advanced along at given trajectory, it is on a trajectory that couldresult in the electrode array piercing the wall, that being the statusof the electrode array. Accordingly, the actuator that is utilized toadvance the electrode array can be an actuator that operates on morethan one degree of freedom, and thus the method 9400 entails controllingthat actuator to change the trajectory of the electrode array insertionbased on the determination. That said, in an alternate embodiment,another actuator can be controlled, such as one of the actuators on orotherwise connected to one of the arms, etc., of the robot assembly, tochange the trajectory of electrode array advancement based on thedetermination.

Note also that in an exemplary embodiment of method 9420, the status ofthe electrode array can be that which corresponds to the electrode arrayhaving pierced the wall of the cochlea. Thus, in an exemplary embodimentof method 9400, the method can include the action of utilizing theactuator utilized in method 91002 retract the electrode array so that itis no longer piercing the wall of the cochlea. Then (or simultaneouslytherewith), method action 9430 is executed to change the trajectory ofthe electrode array advancement so that it is less likely to againpierced the wall of the cochlea. Thus, in an exemplary embodiment, thevarious methods detailed herein can include the action of determining atleast one of whether the electrode array has dislocated from one scaleof the cochlea to another scale of the cochlea or whether such willhappen based on the monitored electrical phenomenon/characteristics.

Note also that the status of the electrode array determined in action9420 could be that of a tip fold over or a buckling or a twisting of theelectrode array, etc.

In an exemplary method of executing method 9100, there is further anaction of guiding advancement of the first portion of the electrodearray into the cochlea using an insertion guide mounted on a supportarm, such as the support arm of the robotic assembly. Note that whilethe embodiments described up to now have tended to be directed towardsan embodiment where there is an actuator that controls the orientationof the insertion guide, in some alternate embodiments, the support armcan be that of a generic rig that is manually moved by the recipient. Inthis regard, by way of example only and not by way of limitation, withrespect to the embodiment of FIG. 85, components 8420 can instead bedamping devices or the like that provide resistance against movement ofone arm relative to another arm, etc., in a manner analogous to thecontraption that is utilized by dentist or the like. That is, in anexemplary embodiment, the surgeon or other healthcare professional movesthe insertion guide manually by applying a force on to the insertionguide to position the insertion guide to a desirable location. Thisforce is sufficient enough to overcome the resistance provided bycomponents 8420 to the overall movement however, the resistance providedby components 8420 is sufficient enough that the guide tool generallystays in the location desired by the surgeon.

In any event, in at least some exemplary embodiments, the angularorientation of the insertion tool is adjustable relative to the cochleavia at least one of the actuator another actuator (if such actuators areused). In an exemplary embodiment, the electricalphenomenon/characteristics that is monitored is a phenomenon indicativeof an orientation of the electrode array inside the cochlea. In thisregard, the orientation can be the insertion angle. In an exemplaryembodiment, the orientation can be the location of one or more portionsof the electrode array relative to one of the walls of the cochlea. Anyorientation that has utilitarian value can be utilized in this exemplarymethod.

Continuing with this method, in an exemplary embodiment, this methodfurther includes the action of controlling at least one of the actuatoror another actuator based on the action of monitoring the electricalphenomenon/characteristics to adjust an orientation of at least aportion of the insertion guide relative to the cochlea, thereby changingthe orientation of the electrode array inside the cochlea relative tothat which was the case when the electrical phenomenon/characteristicswas monitored. In this regard, in an exemplary embodiment, the guidetube of the insertion guide can potentially gimbal or the like orotherwise can be moved by one of the actuators so as to change theorientation of the guide tube. That said, in an alternative embodiment,the entire insertion guide is moved so as to change the orientationthereof. It is noted that orientation can be any orientation about anyaxis of the electrode array. This can correspond to rotation of theelectrode array about any one of its three axes. To be clear, in anexemplary embodiment, the guide tube of the insertion guide can be movedso as to change an approach direction of the electrode array during theinsertion process. In this regard, the guide tube can be adjusted tochange in approach of the electrode array towards a given wall of thecochlea. Indeed, with respect to actions prior to insertion of theelectrode array into the cochlea, the guide tube can be adjusted tochange the approach direction of the guide tube as it is moved towardsthe cochlea prior to contact with the cochlea.

As noted above, some exemplary embodiments of the insertion guide'sdetailed herein have components that are part of a system that enablesthe electrical phenomenon/characteristics to be monitored. In thisregard, in an exemplary embodiment, at least some of the methodsdetailed herein are such that the insertion guide includes an electrode,and the electrical phenomenon/characteristics monitored during themethods is monitored utilizing the electrode.

In some alternate embodiments, some exemplary methods entail insertingan electrode array into a cochlea of the recipient utilizing a roboticapparatus by controlling the robotic apparatus at least partially basedon electrical phenomenon associated with the recipient. As detailedabove, the ECoG measurements, or the voltage, or impedance measurements,etc. correspond to electrical phenomenon associated with the recipient(and in this instance, the electrical phenomenon inside the recipient).Here, the recipient's body influences these measurements. For example,the conductivity of the perilymph in the cochlea corresponds to anelectrical phenomenon of the recipient. This is as contrasted tomeasurements taken by sensor or the like on the robotic assembly, etc.,indicating features associated with the robotic apparatus (e.g., a forceapplied by an actuator with respect to inserting the electrode array,measuring a voltage or a current spike at the actuators, etc.). Indeed,such measurements can be influenced by the recipient's body (e.g.,because the electrode array is wedged against a wall of the cochlea),but those are not electrical phenomenon associated with the recipient.These are physiological phenomenon associated with the insertion of theelectrode array into the recipient, but not physiological phenomenonassociated with the recipient.

Consistent with the teachings above, in an exemplary method, the actionof inserting the electrode array into the cochlea entails makingadjustments to an operation of the robotic apparatus to maintainmeasurements of the physiological phenomenon and/or electricalphenomenon within predetermined parameters. By way of example only andnot by way of limitation, if the impedance and/or voltages are beingmeasured during the insertion of the electrode array into the cochlea(whether such measurements are made during a pause in the advancement ofthe electrode array or whether such measurements are made while theelectrode array is being advanced), the method is executed such that thethese measurements are maintained within the predetermined parameters.Note that in an exemplary embodiment, such as automatically done. By wayof example only and not by way of limitation, the aforementioned controlunit 3810 can be programmed or otherwise can have a script therein thatcontrols the robotic assembly and makes adjustments to the operationthereof so that the measurements are maintained within the predeterminedparameters during the insertion process. Note that in some exemplaryembodiments, these parameters can change as the electrode array isinserted into the cochlea. For example, as noted above, as the electrodearray curls backwards towards the cochleostomy as a result of the spiralshape of the cochlea, the measurements associated with the impedancebetween the various electrodes will change. Thus, in an exemplaryembodiment, the predetermined parameters can be based on insertion depthof the like, and thus these predetermined parameters can be differentand otherwise change during the electrode array insertion process.

In an exemplary embodiment, the action of inserting the electrode arrayinto the cochlea entails making adjustments to the operation of therobotic apparatus to address perturbations of the electrode array in theinsertion process based on the physiological phenomenon/electricalphenomenon. By way of example only and not by way of limitation,perturbations can create an undesirable trajectory of the electrodearray. In an exemplary embodiment, the physical phenomenon can be usedas a basis to make adjustments to the operation of one or more actuatorsof the electrode array.

It is noted that in an exemplary embodiment, the action of inserting theelectrode array into the cochlea of the recipient, utilizing the roboticapparatus, entails utilizing a robotic apparatus by controlling therobotic apparatus at least partially based on a plurality of differentphysiological phenomenon/electrical phenomenon associated with arecipient. By way of example only and not by way of limitation, as notedabove, the voltage measurements can be utilized to determine thatoccurrence of electrode array to fold over has happened or otherwisethat such may be about to occur. Also, the ECoG data can be utilized todetermine the relative location of the electrode array to one of thewalls of the cochlea. In an exemplary embodiment, the method entailscontrolling the robotic apparatus based on a control regime that weightsdata based on the respective electrical phenomenon differently. By wayof example only and not by way of limitation, in an exemplaryembodiment, the control regime that controls the robotic assembly can besuch that the insertion process is controlled such that actions will betaken to reduce the occurrence or otherwise the likelihood of tip foldover at the expense of increasing the likelihood of some otherdeleterious results or otherwise less than utilitarian result occurs.For example, the control regime can be configured such that in ascenario where, for example, the electrode array is intended to belocated at the mid-scala position, during the insertion process,electrical phenomenon indicative of tip fold over or the likelyoccurrence thereof will drive the insertion process such that tip foldover can be avoided, but the electrode array may not be located exactlyat the mid-scala position. Of course, in some alternate embodiments, thereverse can be true—tip fold over can be deemed more acceptable than adeviation from the mid-scala position. The point is that the datarelated to the plurality of physical phenomenon can be weighted by thecontrol regime, such as the control regime of the control unit 8310, inat least some exemplary embodiments.

In some exemplary embodiments, the control unit that controls therobotic apparatus in general, and one or more of the actuators inparticular, is configured to receive input indicative of an insertionregime of the electrode array. In this regard, in at least someexemplary embodiments, a given electrode array may not necessarily beinserted or otherwise positioned in a given cochlea the same as thatwhich would be the case for another recipient. By way of example, someelectrodes are inserted further into the cochlea than others (absolutedistance (relative to the length of the electrode array), angularinsertion depth, etc.). Accordingly, a given insertion regime cancorrespond to that which results in a given absolute distance and/or agiven angular insertion depth. Still further, some insertion regimescorrespond to that which results in the electrode array being in amid-scala position (no contact with the cochlea walls that extend alongthe longitudinal axis of the electrode array, or at least relativelyminimal contact). Accordingly, a given insertion regime can correspondto that which results in the electrode array being in a mid-scalaposition at the end of the insertion thereof. Note that in someexemplary embodiments, such an insertion regime can result in theelectrode array contacting the walls of the cochlea during insertion.That said, in some alternate embodiments, there is an insertion regimethat is such that the electrode array does not contact the walls alongthe longitudinal axis of the electrode array, or at least has minimalcontact therewith. Also, some insertion regimes correspond to that whichresults in the electrode array being positioned against the modioluswall of the cochlea. Thus, a given insertion regime can correspond tothat which results in the electrode array being positioned against themodiolus wall. That said, in some alternate embodiments, there exists aninsertion regime that is such that during insertion of the electrodearray, the electrode array does not come into contact with the modioluswall of the cochlea. In an exemplary embodiment of this insertionregime, the electrode array comes into contact after the electrode arrayis inserted into the cochlea (or at least the desired length of theelectrode array has been placed into the cochlea). Also, in someexemplary embodiments, the insertion regime is such that the electrodearray never comes into contact with the modiolus wall. Still further, insome exemplary insertion regimes, the electrode array is inserted suchthat it slides along the lateral wall of the cochlea during insertion.Thus, an exemplary insertion regime entails that which maintains theelectrode array in contact with the lateral wall of the cochlea duringadvancement of the electrode array. Note that this can be such eventhough the electrode array ultimately moves away from the lateral wall,at least in part, after advancement, or at least after advancementcommences. The point is, for a given electrode array, there are manyinsertion regimes.

Thus, as noted above, in an exemplary embodiment, the control unit thatcontrols the robotic apparatus is configured to receive input indicativeof an insertion regime of the electrode array. By way of example onlyand not by way of limitation, the control unit can correspond to apersonal computer or the like with a program thereon that asks thesurgeon or other user of the robotic apparatus what insertion regime theuser would like. Such can provide a list of various insertion regimes.The control unit can be configured to enable the user to input dataindicative of the desired insertion regime. Based on this input, thecontrol unit can automatically coordinate the insertion regime with databased on the electrical phenomenon/characteristics of the recipient tocontrol the actuation of the actuator(s) of the robot apparatus toachieve controlled actuation of the actuator based on electricalphenomenon/characteristics of the recipient. For example, with respectto an insertion regime where the electrode array will be inserted tohave a specific insertion angle, impedance between the pertinentelectrodes can be monitored and when an impedance is measured that isindicative of the electrode array reaching the desired insertion angle,further advancement electrode array is halted by halting actuation ofactuator 7720 for example. Still further by way of example, an insertionregime can be a mid-scala insertion regime, and the pertinent electricalphenomenon/characteristics detailed herein can be measured or otherwiseevaluated so as to control the robot apparatus to angle the insertionguide relative to the cochlea such that the electrode array is insertedin a manner that should result in a mid-scala position.

Corollary to the above, in an exemplary embodiment, with respect to thecontrol unit 8310, in an exemplary embodiment, the control unit isconfigured to control the robotic assembly to move the electrode arrayinto the cochlea according to a general insertion regime, and make microadjustments to at least one of (i) the general insertion regime or (ii)control output to the robotic assembly from the control unit that isbased on the general insertion regime, wherein the adjustments are basedon the received recipient electrical data. For example, in an exemplaryscenario where the insertion regime corresponds to advancing theelectrode array such that it is generally in constant contact with thelateral wall of the cochlea, the control unit 8310 will have controldata therein supporting such a general insertion regime, which data isused by the control unit 8310 to control the actuators of the robotapparatus to achieve the desired results of that general insertionregime. For example, the general insertion regime can include controldata that causes the robot apparatus to adjust the angular orientationof the insertion guide at different insertion depths of the electrodearray. Because the control data of the general insertion regime isdeveloped based on an ideal situation, and during the process ofadvancing the electrode array into the cochlea, deviations from thatideal situation will result, the control unit is configured to makemicro-adjustments to the general insertion regime, or more specifically,to the control data of the general insertion regime. In this regard, inan exemplary scenario where the original insertion regime was such thatafter the electrode array was inserted a length of X millimeters, theangle of the insertion guide was to be changed Y degrees. However, basedon the received recipient electrical data, the control unit can beconfigured so as to adjust the insertion regime such that when theelectrode array is inserted a length of X millimeters, the angle of theinsertion guide is instead changed by Z degrees.

That said, in some alternate embodiments, the micro-adjustments are madeto the control output from the control unit to the robotic assembly.That is, the underlying general insertion regime is not changed, but theoutput to the actuators of the robotic assembly is changed or otherwiseadjusted from that which would otherwise be the case so as to take intoaccount the received recipient electrical data. That is, instead ofchanging the general insertion regime, or more specifically, the controldata, the adjustments are made to the output. This is analogous toapplying a correction factor to the output.

Any device, system, and/or method that will enable adjustments duringinsertion of the electrode array by the robot apparatus based onreceived recipient electrical data or the like can be utilized in atleast some exemplary embodiments.

As will be understood, there are a plurality of different insertionregimes that can be selected for a given electrode array. In anexemplary embodiment, the control unit 8310 is configured to control therobotic assembly to move the electrode into the cochlea according to arespective insertion regime that is a member of a plurality of differentinsertion regimes. Again, with reference to the above scenario where thecontrol unit includes a display that displays an insertion regimecorresponding to a mid-scala insertion regime, and an insertion regimethat corresponds to a lateral wall insertion regime, etc., such cancorrespond to the plurality of different insertion regimes. Otherinsertion regimes can also be included within the plurality of differentinsertion regimes. In an exemplary embodiment, these different insertionregimes are predetermined insertion regimes, and the user can select oneof the insertion regimes from the various insertion regimes. The controlunit 8310 is configured to automatically control the robotic apparatusin general, and the actuators thereof in particular, to achieveelectrode array insertion according to that insertion regime.

In an exemplary embodiment, the control unit is configured to weightdifferent electrical features of the electrical data based on therespective insertion regime and control the robotic assembly differentlybased on the different weights. In this regard, some electrical featureswill be more prominent with respect to a given insertion regime. Forexample, with respect to a mid-scala insertion regime, electricalfeatures that enable the distance of the electrode array to a given wallof the cochlea will be weighted more heavily than other electricalfeatures. Conversely, with respect to a lateral wall insertion regime,electrical features indicative of tip fold over may be weighted lower insuch a regime with respect to other regimes because it is less likelythat tip fold over may occur while the electrode array is being drivenalong the lateral wall (at least with respect to a curved electrode).

It is noted that while the various teachings detailed herein aresometimes described in terms of electrical features/electricalphenomenon associated with a recipient and/or electricalphenomenon/characteristics of the recipient, it is also noted that thesefeatures/phenomenon need not necessarily be identified. That is, thevarious measurements associated with the methods and/or devices detailedherein can be used as a proxy for these features/phenomena. Accordingly,any disclosure herein of an electrical feature and/or an electrcialphenomenon and/or an electrical feature phenomenon associated with therecipient corresponds to a disclosure of measurements relating thereto,they can be used by the control unit or other system to achieve theteachings detailed herein. Thus, a disclosure of an electricalphenomenon that is indicative of tip fold over corresponds to adisclosure of measurements from measurement devices of the apparatusesdetailed herein and/or variations thereof resulting from such electricalphenomenon (and vice versa).

Also in view of the above, it is to be understood that in an exemplaryembodiment, the systems and devices disclosed herein and/or variationsthereof can be configured to receive user input and establish anautomated insertion regime for the electrode array into the cochleabased on the received user input. In this regard, the user can be asurgeon or other healthcare professional. That said, in an extremeexample, the user can be the recipient himself or herself, such as mightresult in an exemplary scenario associated with a long-term deep spacemission. With respect to this exemplary embodiment, the system ordevice, etc. is configured to automatically determine if the insertionregime is being followed based on recipient physiologicaldata/electrical data.

It is noted that an exemplary insertion regime can correspond to thatfor a straight electrode. Corollary to this is that an exemplaryinsertion regime can correspond to that for a curved electrode. In anexemplary embodiment, the control unit 8310 can be configured toevaluate data based on the electrical data and determine if theinsertion regime is being followed. This can be done during theinsertion process of the electrode array. That said, in an alternateembodiment, this can be done after the electrode array is inserted as acheck to determine whether or not the electrode array has been properlyplaced.

Another way of considering the application of at least some of theteachings detailed herein is in view of an exemplary method thatincludes the action of determining an electrode array surgery resultsspecies from a genus of electrode array surgery results. Again, thegenus of such results could be that of a mid-scala electrode arraylocation or a modiolus wall electrode array location, etc. In anexemplary embodiment, a surgeon or other healthcare professional choosesan exemplary species from the genus of surgery results. This methodfurther includes establishing a control regime based on the determinedelectrode array surgery result species. In this exemplary method, theinsertion of the electrode array into the cochlea is based at least inpart on the established control regime. For example, control unit 8310can be configured to receive input indicative of how the surgeon wantsthe electrode array to ultimately be placed in the cochlea at theresults of the surgery. The control unit 8310 is configured to develop acontrol regime based on that input. That is, the control unit canevaluate how it should control the actuators etc. of the roboticapparatus or the like so as to achieve that result. The control unit canbe configured to develop a control regime or otherwise select a controlregime to achieve that result. The control unit can thus control therobotic apparatus of the like during insertion of the electrode arrayinto the cochlea based on the control regime, the idea being is that thecontrol regime will result in the selected electrode array surgeryresult.

Note also that in an exemplary method there includes method actions thatentail inputting at least one of a plurality of inputs into a controllerof a robotic electrode array insertion system. In an exemplaryembodiment, this robotic electrode array insertion system can correspondto any of the pertinent apparatuses detailed herein and/or variationsthereof. The one or more of the plurality of inputs can be indicative ofrespective parameters associated with the electrode array. By way ofexample only and not by way of limitation, the input can correspond towhether or not the electrode array is a straight electrode array or acurved electrode array. Still further by way of example only and not byway of limitation, the input can correspond to whether or not theelectrode array includes a stylet. The input can correspond to whetheror not the electrode array has the aforementioned squarecross-section/rectangle across the skin detailed above, or whether thatelectrode array has more than oval or circular shaped. The input cancorrespond to the number of electrodes in the electrode array. The inputcan correspond to whether or not the electrode array is a so calledshort electrode array. Any type of input relating to the electrode arraycan be the input in at least some exemplary embodiments. Still further,in this exemplary method, control of the robotic apparatus is executedat least in part based on this input. That is, in an exemplaryembodiment, the control unit 8310 can be configured to develop a controlregime or otherwise select a control regime based on the input relatedto the electrode array. By way of example only and not by way oflimitation, actions associated with controlling the robotic apparatusduring the insertion process could be different if the electrode arrayincludes a straightening stylet as opposed to an electrode array thatdoes not include a straightening stylet. Still further, actionsassociated with controlling the robotic apparatus during the insertionprocess can be different if the electrode array is a curled electrodearray as opposed to a straight electrode array.

It is noted that some exemplary embodiments further include inputtingdata into a controller of a robotic electrode array insertion systemindicative of a status of an electrode array. In this regard, accordingto an exemplary embodiment, as noted above, some exemplary insertionguides enable automatic determination of the length of the electrodearray that has been inserted into the cochlea (e.g., by monitoringpassage of the electrodes as they pass a sensor). In this regard, in anexemplary embodiment, the sensors or the like of the insertion guide arenot signal communication in one way or another with the control unit8310, such as by way of example only and not by way of limitation, thesignal communication system between the communication unit of theinsertion guide and the control unit as detailed above. During theinsertion process, the insertion guide can communicate data indicativeof the distance that the electrode array has been inserted into thecochlea, or at least the distance inserted relative to a set point withrespect to the insertion guide, which set point is known in the greaterscheme of things in a manner that can have utilitarian value withrespect to controlling the insertion process of the electrode array.Accordingly, in an exemplary embodiment, the action of inputting datainto the controller of a robotic electrode array can correspond to theautomatic transmission of the data relating to the insertion depth tothe controller 8310.

Still further, in an exemplary embodiment, control of the roboticapparatus is executed based at least in part by comparing data relatedto the input (e.g., insertion depth measured by the insertion guidesensors) to data related to the electrical phenomenon upon which therobotic apparatus is controlled. In this regard, in an exemplaryembodiment, there can be a predetermined set of ideal electricalphenomenon that should be seen or otherwise exists, which electricalphenomenon change with distance that the electrode array is insertedinto the cochlea. By comparing the input indicative of a given distanceto which the electrode array has been inserted to the data relating tothe p electrical phenomenon, a “sanity check” can be performed todetermine or otherwise estimate whether or not the insertion process isgoing as planned. Alternatively, and/or in addition to this, such inputcan be utilized to discount or otherwise change the weightings ofcertain electrical phenomena as compared to other certain electricalphenomena. For example, electrical phenomena associated with thefold-over could be weighted more heavily when only a small portion or aminimal portion of the electrode array is inserted into the cochlea, andweighted less heavily when 90% or 95% of the electrode array is insertedin the cochlea, etc. It is noted that this is just one exemplaryembodiment. Another exemplary embodiment could entail avoiding contactwith the modiolis wall. In an exemplary embodiment, contact with themodiolis wall when only a small portion or a small length of theelectrode array is inserted to the cochlea could correspond to ascenario where continued insertion of the electrode array to the cochleais immediately halted. Conversely, an electrical phenomenon indicativeof contact with that wall when 90 or 95% of the electrode array isinserted in the cochlea might not necessarily result in halting furtherinsertion into the cochlea.

While the above embodiments have been directed towards automaticcommunication between the insertion guide and the control unit, in someembodiments, the surgeon or the like can input data directly into thecontroller of the robotic electrode array insertion system indicative ofa status of an electrode array within the cochlea. In this regard, itcould be that some exemplary systems are not as sophisticated as otherexemplary systems. By way of example only and not by way of limitation,a scenario can exist where the surgeon quasi-dictates the insertiondepth of the electrode array into the control unit of the roboticapparatus. By way of example only and not by way of limitation, ascenario can exist where the robotic apparatus does not have the abilityto determine the distance or the insertion amount of the electrodearray, for whatever reason. Instead, the surgeon can talk, and thesystem, utilizing a voice recognition system or the like, can receivethe input.

Note further that in some exemplary embodiments, there exist methodsthat include a method action of outputting data relating to theelectrode array during the action of insertion, which output comes froma robotic electrode array insertion system. In an exemplary embodiment,there exists a method action that entails manually adjusting operationof the robotic apparatus based on the output. Such an exemplaryembodiment can have utilitarian value with respect to combining theautomatic insertion techniques with manual insertion techniques. Asnoted above, some exemplary embodiments can utilize a quasi-fly by wiresystem where the surgeon controls the overall insertion process, but thecontrol unit 8310 controls the finer points of the insertion process. Insuch an exemplary embodiment, there can be utilitarian value withrespect to the surgeon or other healthcare professional receiving outputrelating to the electrode array during the action of insertion with therobotic system. This output can be utilized by the surgeon to allow himor her to make adjustments to his or her actions insertion process. Notealso that in an exemplary embodiment, such exemplary methods can serveas an override or the like to the automatic insertion process.

Note that the teachings detailed herein utilizing machines to move theelectrode array relative to the cochlea can have utilitarian value withrespect to providing controlled insertion of the electrode array intothe cochlea. For example, utilizing an actuator to drive the electrodearray into the cochlea can have utilitarian value with respect toenabling a relatively slow insertion speed of the electrode array intothe cochlea. As with many tasks performed by a human being, a humanbeing will become fatigued the longer that the task is executed. A humanbeing could hold a bucket of water in an outstretched arm for a numberof seconds, but such may not necessarily be possible for a temporalperiod lasting a number of minutes. The same is also the case withrespect to the surgeon. There is only so long that the surgeon can holdthe electrode array in place against the cochlea during the insertionprocess before fatigue takes over and the likelihood of a fatiguerelated injury to the recipient or otherwise a deleterious effectassociated with the insertion of the electrode array occurs. Utilizingthe machines detailed herein, such is not necessarily the case. Forexample, the actuators detailed herein can be utilized to drive theelectrode array into the cochlea at a speed of no more than 2 mm/s or nomore than 1.5 mm/s 1 mm/s, or no more than 0.5 mm/s, or not more than0.25 mm/s, or no more than 0.2 or 0.15 or 0.1 or 0.075 or 0.05 or 0.025or 0.02 or 0.01 or 0.005 mm/s or less (or any value or range of valuestherebetween in 0.001 mm/s).

Note also that such exemplary micro-movement capabilities are alsoapplicable to the other actuators of the robotic apparatus. In thisregard, such micro-movement can be applied to insertion of theintracochlear portion of the insertion guide utilizing the roboticapparatus. In this regard, the aforementioned speeds associated withelectrode array insertion are also applicable to movements of theinsertion guide into the cochlea or towards the cochlea.

It is noted that any of the method actions detailed herein and/or thefunctionalities of the given tools and/or systems detailed herein existor can exist while the surgeon is inserting the electrode array into therecipient. This means that the surgeon is actually moving the electrodearray into the recipient, not just during the procedure spanning a firsttemporal period where only a subset of that first temporal periodinvolves actually moving the electrode array into the cochlea.

While various embodiments detailed herein have been in some instancesdirected to correlating various phenomenon with other data, in anexemplary embodiment, the method actions detailed herein associated withinsertion of the electrode array can be executed until data is receivedindicating that such should be stopped. For example, in an exemplaryembodiment, the robotic apparatuses detailed herein can machine advancethe electrode array into the cochlea utilizing the actuators detailedherein and/or variations thereof until data is received indicating thatadvancement should be stopped. Such can have utilitarian value, by wayof example only and not by way of limitation, with respect to theexemplary handheld tool 8200 of FIG. 82. In an exemplary embodiment, thehand tool 8200 can be utilized to machine dry the electrode array intothe cochlea until certain types of data are received, at which point asignal from a control unit or the like is sent to the actuator 7720,such as via the electrical lead connected to connector 67405, to shutdown the actuator. In this regard, this can be the opposite of theexemplary scenario detailed above where the surgeon exercises overridecapabilities over the robotic system. Here, it is the control unit thatcan exercise override over what the surgeon is doing. Indeed, in anexemplary embodiment, both the surgeon and the control unit can exerciseoverride. Note while this exemplary scenario has been directed towardsthe embodiment of FIG. 82, in some alternate embodiments, such scenarioscan be directed towards the other apparatuses detailed herein and/orvariations thereof.

FIG. 96 depicts an exemplary flowchart representing a regime thatutilizes feedback in the form of data from any of the varioussensors/measurement techniques detailed herein, etc. Specifically, FIG.96 includes action 9610, which entails actuating the actuator. In thisexemplary embodiment, there is action 9620, which entails halting theactuator. Action 9630 entails receiving data from measurements (e.g.,ECoG measurements, etc.—Action 9630 can instead be data relating to anyof the electrical properties detailed herein and/or variations thereofof the recipient, etc.) Action 9640 entails evaluating the data. Withrespect to this regime, if the evaluation of the data at action 9640indicates acceptable data, the routine goes back to action 9610. This iscontinued until an event occurs that breaks the routine at action 9650.This could be a result of the evaluation at action 9640 indicating thatthe data is not acceptable.

FIG. 97 depicts another exemplary flowchart representing a regime thatutilizes feedback in the form of data from any of the varioussensors/measurement techniques detailed herein, etc. Specifically, FIG.97 includes action 9610, which entails actuating the actuator. In thisexemplary embodiment, the actuator is not halted unlike the embodimentof FIG. 96. Action 9630 entails receiving data from measurement. Action9640 entails evaluating the data. With respect to this regime, if theevaluation of the data at action 9640 indicates acceptable data, theroutine goes back to action 9610. This is continued until an eventoccurs that breaks the routine at action 9650. This could be a result ofthe evaluation at action 9640 indicating that the data is notacceptable.

FIG. 98 depicts yet another exemplary flowchart representing a regimethat utilizes feedback in the form of data from any of the varioussensors/measurement techniques detailed herein, etc. This routinegenerally follows that of FIG. 97, except that the routine begins withthe action 9810, which entails receiving data from measurements. In thisregard, it is noted that at least some exemplary embodiments can utilizethe measurements detailed herein to evaluate whether or not the actuatorshould begin to be actuated in the first instance.

In view of the above, it can be seen that in an exemplary embodiment,there is an apparatus, comprising, an actuator, an electrode arraysupport, wherein the apparatus is configured to insert an electrodearray into a cochlea via controlled actuation of the actuator, whereinthe controlled actuation is at least partially based on data that is atleast partially based on electrical characteristics associated with therecipient. In view of the above, it can be seen that in an exemplaryembodiment, there is an apparatus, as described above and/or below,wherein the controlled actuation is at least partially based on ECoGdata, wherein the ECoG data is based on the electrical characteristicsof the recipient. In view of the above, it can be seen that in anexemplary embodiment, there is an apparatus, as described above and/orbelow, wherein the controlled actuation is at least partially based onvoltage measurements relating to energizement of an electrode inside therecipient data, wherein the voltage measurements are based at least inpart on the electrical characteristics associated with the recipient. Inview of the above, it can be seen that in an exemplary embodiment, thereis an apparatus, as described above and/or below, wherein the controlledactuation is at least partially based on evoked compound actionpotentials data, wherein the neural response data is based at least inpart on the electrical characteristics associated with the recipient. Inview of the above, it can be seen that in an exemplary embodiment, thereis an apparatus, as described above and/or below, wherein the apparatushas a control unit configured to receive input indicative of aninsertion regime of the electrode array, and the apparatus is configuredto automatically coordinate the insertion regime with data based on theelectrical characteristics associated with the recipient to control theactuation of the actuator to achieve the controlled actuation of theactuator.

In view of the above, it can be seen that in an exemplary embodiment,there is an apparatus, as described above and/or below, wherein theapparatus is configured to receive input indicative of the electricalcharacteristics associated with the recipient, develop data indicativeof a position of the electrode array within the cochlea based on theinput, and adjust the control of the actuation of the actuator based onthe developed data indicative of the position of the electrode array. Inview of the above, it can be seen that in an exemplary embodiment, thereis an apparatus, as described above and/or below, wherein the electrodearray support is an insertion tool including an electrode mountedthereon, wherein the apparatus is configured to utilize the electrode toobtain data indicative of the electrical characteristics associated withthe recipient, and the actuator is configured to drive the electrodearray relative to the insertion tool to insert the electrode array intothe cochlea.

In view of the above, it can be see that in an exemplary embodiment,there is a system, such as any of the systems detailed above, comprisinga robotic assembly configured to move an implantable medical devicerelative to an anatomical structure of a recipient, and a control unitconfigured to receive data from the implantable medical device andcontrol the robotic assembly based at least in part on the receiveddata. In an exemplary embodiment, the data includes measurements ofelectrical phenomenon inside the recipient. In an exemplary embodiment,the implantable medical device is a component of a cochlear implant, thesystem is a cochlear implant electrode array insertion system, therobotic system includes an actuator configured to advance and retractthe electrode array, and the control unit controls actuation of theactuator to advance and retract the electrode array into and out of thecochlea based on the data from the implantable medical device.

In an exemplary embodiment, there is an apparatus as described aboveand/or below, wherein, the apparatus includes a control unit configuredto provide the controlled actuation of the actuator at least partiallybased on the electrical characteristics associated with the recipient,the the apparatus is configured to place the control unit into signalcommunication with a cochlear implant of which the electrode array is apart, the cochlear implant being configured to obtain data indicative ofthe electrical characteristics associated with the recipient, and theapparatus is configured to convey data based on the obtained data to thecontrol unit via the established signal communication with the cochlearimplant so that the control unit can provide the controlled actuation ofthe actuator at least partially based on the electrical characteristicsassociated with the recipient. In an exemplary embodiment, there is asystem as described above and/or below, wherein the control unit isconfigured to control the robotic assembly to move the electrode intothe cochlea according to a respective insertion regime that is a memberof a plurality of different predetermined insertion regimes, and thecontrol unit is configured to weight different features of the databased on electrical phenomenon inside the recipient based on therespective insertion regime and control the robotic assembly differentlybased on the different weights. In an exemplary embodiment, there is asystem as described above and/or below, wherein the system is configuredto receive user input and establish an automated insertion regime forthe electrode array into the cochlea based on the received user input,and the system is configured to automatically determine if the insertionregime is being followed based on the electrical phenomenon inside therecipient.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising determining at least one of whether theelectrode array has twisted or will twist based on the monitoredelectrical phenomenon, and controlling the actuator to at least one ofretract the electrode array or halt advancement of the electrode arrayupon the determination. In an exemplary embodiment, there is a method asdescribed above and/or below, further comprising utilizing at least oneof ECoG, voltage measurements relating to energizement of an electrodeinside the recipient or measurements of evoked compound actionpotentials during the first temporal period to monitor the electricalphenomenon. In an exemplary embodiment, there is a method as describedabove and/or below, further comprising guiding advancement of the firstportion of the electrode array into the cochlea using an insertion guidemounted on a support arm, wherein an angular orientation of theinsertion tool is adjustable relative to the cochlea via at least one ofthe actuator or another actuator, wherein the electrical phenomenonmonitored is phenomenon indicative of an orientation of the electrodearray inside the cochlea, and the method further comprises controllingat least one of the actuator or the another actuator based on the actionof monitoring the electrical phenomenon to adjust an orientation of atleast a portion of the insertion guide relative to the cochlea, therebychanging at least one of the orientation of the electrode array or adirection of approach of the electrode array inside the cochlea relativeto that which was the case when the electrical phenomenon was monitored.

In an exemplary embodiment, there is a method as described above and/orbelow, wherein the insertion guide includes an electrode, and theelectrical phenomenon is monitored using the electrode. In an exemplaryembodiment, there is a method as described above and/or below, furthercomprising determining at least one of whether the electrode array hasdislocated from one scala of the cochlea to another scala of the cochleaor that such will happen based on the monitored electrical phenomenon,and controlling the actuator to at least one of retract the electrodearray or halt advancement of the electrode array upon the determination.

In an exemplary embodiment, there is a method as described above and/orbelow, further comprising inputting data into a controller of a roboticelectrode array insertion system indicative of a status of an electrodearray, wherein control of the robotic apparatus is executed based atleast in part by comparing data related to the input to data related tothe electrical phenomenon associated with the upon which the roboticapparatus is controlled. In an exemplary embodiment, there is a methodas described above and/or below, further comprising outputting datarelating to the electrode array during the action of insertion from arobotic electrode array insertion system, wherein the robotic apparatusis part of the robotic electrode array insertion system, and manuallyadjusting operation of the robotic apparatus based on the output. In anexemplary embodiment, there is a method as described above and/or below,further comprising determining that the electrode array has buckledbased on the phenomenon associated with the recipient, automaticallyhalting insertion of the electrode array upon the determination that theelectrode array has buckled.

Any disclosure of any method action detailed herein corresponds to adisclosure of a device and/or a system for executing that method action.Any disclosure of any method of making an apparatus detailed hereincorresponds to a resulting apparatus made by that method. Anyfunctionality of any apparatus detailed herein corresponds to a methodhaving a method action associated with that functionality. Anydisclosure of any apparatus and/or system detailed herein corresponds toa method of utilizing that apparatus and/or system. Any feature of anyembodiment detailed herein can be combined with any other feature of anyother embodiment detailed herein providing that the art enables such,unless such is otherwise noted.

While various embodiments of the present invention have been describedabove, it should be understood that they have been presented by way ofexample only, and not limitation. It will be apparent to persons skilledin the relevant art that various changes in form and detail can be madetherein without departing from the scope of the invention.

What is claimed is:
 1. A system, comprising: a robotic assemblyconfigured to move an implantable medical device relative to ananatomical structure of a recipient; and a control unit configured toreceive data from the implantable medical device and control the roboticassembly based at least in part on the received data.
 2. The system ofclaim 1, wherein: the data includes measurements of electricalphenomenon inside the recipient.
 3. The system of claim 1, wherein:implantable medical device is a component of a cochlear implant; thesystem is a cochlear implant electrode array insertion system; therobotic system includes an actuator configured to advance and retractthe electrode array; and the control unit controls actuation of theactuator to advance and retract the electrode array into and out of thecochlea based on the data from the implantable medical device.
 4. Thesystem of claim 1, wherein: the robotic assembly includes an actuatorthat moves the implantable medical device and an electrode arraysupport, wherein the system is configured to insert an electrode arrayinto a cochlea via controlled actuation of the actuator, wherein thecontrolled actuation is at least partially based on data that is atleast partially based on electrical characteristics associated with therecipient, the electrical characteristics corresponding to the receiveddata.
 5. The system of claim 4, wherein: the controlled actuation is atleast partially based on ECoG data, wherein the ECoG data is based onthe electrical characteristics of the recipient.
 6. The system of claim4, wherein: the controlled actuation is at least partially based onvoltage measurements relating to energizement of an electrode inside therecipient data, wherein the voltage measurements are based at least inpart on the electrical characteristics associated with the recipient. 7.The system of claim 4, wherein: the controlled actuation is at leastpartially based on evoked compound action potentials data, wherein theneural response data is based at least in part on the electricalcharacteristics associated with the recipient.
 8. A system, comprising:a robotic assembly configured to move an electrode array relative to thecochlea; and a control unit configured to receive data based onelectrical phenomenon inside the recipient and control the roboticassembly based at least in part on the received data.
 9. The system ofclaim 8, wherein: the system is configured to evaluate the data based onelectrical phenomenon inside the recipient to develop data indicative ofa position of the electrode array relative to the cochlea; and theapparatus is configured to control the robotic assembly while moving theelectrode array into the cochlea based on the developed data indicativeof the position of the electrode array.
 10. The system of claim 8,wherein: the control unit is configured to receive telemetry from animplantable system of which the electrode array is a part, wherein thereceived data based on electrical phenomenon inside the recipient isbased on the telemetry.
 11. The system of claim 8, wherein: the controlunit is configured to control the robotic assembly to move the electrodearray into the cochlea according to a general insertion regime and makemicro adjustments to at least one of (i) the general insertion regime or(ii) control output to the robotic assembly from the control unit thatis based on the general insertion regime, wherein the adjustments arebased on the received data based on electrical phenomenon inside therecipient.
 12. The system of claim 8, wherein: the control unit isconfigured to evaluate the data based on electrical phenomenon insidethe recipient to determine at least one of whether a deleterious arrayinsertion event has occurred or is likely to occur; and the control unitis configured to control the robotic assembly based at least in part onthe evaluation.
 13. The system of claim 12, wherein: the control of therobotic assembly comprises halting movement of the electrode array upona determination of at least one of that the deleterious array insertionevent has occurred or is likely to occur.
 14. A method, comprising:advancing at least a first portion of an electrode array into a cochleaof a recipient during a first temporal period at least partiallyassisted by activation of an actuator that moves the electrode array;monitoring an electrical phenomenon within the recipient at least one ofduring the first temporal period or during a second temporal periodsubsequent to the first temporal period; and controlling the actuatorbased on the action of monitoring.
 15. The method of claim 14, furthercomprising: determining at least one of that a deleterious event hasoccurred or will occur with respect to the electrode array based on themonitored electrical phenomenon; and controlling the actuator to atleast one of halt advancement of the electrode array or retract theelectrode array based on the determination.
 16. The method of claim 14,further comprising: determining a status of the electrode array based onthe monitored electrical phenomenon; and controlling the actuator to atleast one of halt advancement of the electrode array or retract theelectrode array based on the determination.
 17. The method of claim 14,further comprising: determining at least one of that an electrode arraytip fold over has occurred or will occur based on the monitoredelectrical phenomenon; and controlling the actuator to at least one ofhalt advancement of the electrode array or retract the electrode arraybased on the determination.
 18. The method of claim 14, furthercomprising: determining an angular insertion depth of the electrodearray based on the monitored electrical phenomenon; and controlling theactuator to at least one of halt advancement of the electrode array orretract the electrode array based on the determined angular insertiondepth.
 19. The method of claim 14, wherein: the action of advancing thefirst portion of the electrode array into the cochlea of the recipiententails controlling the actuator at least partially based on respectivedata based on a plurality of different physiological phenomenonassociated with the recipient based on the monitored electricalphenomenon; and control of the actuator is based on a control regimethat weights the respective data based on the physiological phenomenondifferently.
 20. The method of claim 14, further comprising: insertingthe first portion of the electrode array into the cochlea at a speed ofno more than 0.25 mm per second.
 21. A method, comprising: inserting anelectrode array into a cochlea of a recipient utilizing a roboticapparatus by controlling the robotic apparatus at least partially basedon electrical phenomenon associated with the recipient.
 22. The methodof claim 21, wherein: the action of inserting the electrode array intothe cochlea comprises making adjustments to an operation of the roboticapparatus to maintain measurements of the electrical phenomenonassociated with the recipient within predetermined parameters.
 23. Themethod of claim 21, wherein: the action of inserting the electrode arrayinto the cochlea entails making adjustments to the operation of therobotic apparatus to address perturbations of the electrode array in theinsertion process based on the on electrical phenomenon associated withthe recipient.
 24. The method of claim 21, further comprising:determining an electrode array surgery result species from a genus ofelectrode array surgery results; and establishing a control regime basedon the determined electrode array surgery result species, wherein theinsertion of the electrode array into the cochlea is based at least inpart on the established control regime.
 25. The method of claim 21,further comprising: determining a proximity of the electrode array to awall of the cochlea based on the electrical phenomenon associated withthe recipient; and controlling the robotic apparatus to change atrajectory of electrode array advancement based on the determinedproximity of the electrode array to the wall of the cochlea.
 26. Themethod of claim 21, wherein: the action of inserting the electrode arrayinto the cochlea of the recipient utilizing the robotic apparatusentails utilizing the robotic apparatus by controlling the roboticapparatus at least partially based on data based on a plurality ofdifferent electrical phenomenon associated with the; and control of therobotic apparatus is based on a control regime that weights the databased on the respective electrical phenomenon associated with thedifferently.
 27. The method of claim 21, further comprising: inputtingat least one of a plurality of inputs into a controller of a roboticelectrode array insertion system indicative of respective parametersassociated with the electrode array, wherein the robotic apparatus ispart of the robotic electrode array insertion system, wherein control ofthe robotic apparatus is executed based at least in part on the input.28. The method of claim 21, further comprising: inputting data into acontroller of a robotic electrode array insertion system indicative of astatus of an electrode array, wherein control of the robotic apparatusis executed based at least in part by comparing data related to theinput to data related to the electrical phenomenon associated with theupon which the robotic apparatus is controlled.
 29. The system of claim8, wherein: the control unit is configured to control the roboticassembly to move the electrode into the cochlea according to arespective insertion regime that is a member of a plurality of differentpredetermined insertion regimes; and the control unit is configured toweight different features of the data based on electrical phenomenoninside the recipient based on the respective insertion regime andcontrol the robotic assembly differently based on the different weights.30. The method of claim 14, further comprising: determining at least oneof whether the electrode array has twisted or will twist based on themonitored electrical phenomenon; and controlling the actuator to atleast one of retract the electrode array or halt advancement of theelectrode array upon the determination.